Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Job overview Support Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries), and provides scientific justification and update status of project work as needed. Discover Impactful Work! • Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. • Works on technical/scientific process/product/project activities to implement strategies and technical solutions. • Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients. • Makes decisions that involve direct application of technical knowledge. A Day in the Life. • Support completion of studies, tech transfer, commercial scale-up and support process validation. • Actively participate in problem solving and project results for formulations, equipment and processes. • Write/revise work orders for existing processes, FORMs, reports, memos, and protocols. • Support projects, implement change control actions. • Collects data for statistical analysis. Can support interpretation and summary of data. Keys to Success Education: • Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science. Experience: • Bachelors and 1+ year of related experience PREFFERED. • Experience in a CMO or Pharmaceutical product development field PREFERRED. Equivalency: • Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: • Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry. • Detailed knowledge of Good Manufacturing Practices. • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. • Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients. • Ability to work on multiple projects simultaneously. • Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. • Ability to keep current with scientific literature and industry trends relating to process technologies. • Ability to run technical solutions. • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
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Full TimeVia Partner
TS
Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints
HQI 83
Greenville, North Carolina, USA1d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Excellent Benefits Package Review our company’s Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 5% Tuition Reimbursement – eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Location/Division Specific Information Greenville, NC Schedule: Monday–Friday, standard business hours | Hybrid flexibility: Work from home one day per week Travel: Approximately 0–10% Discover Impactful Work: Join our Quality Systems & Compliance leadership team and help shape the future of quality across our growing pharmaceutical and medical device operations. As a Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints, you will oversee critical quality programs that support regulatory compliance, effective investigations, corrective and preventive actions, and customer complaint management across our expanding business. This is an opportunity to lead a focused team of quality professionals while collaborating across functions to solve complex challenges, strengthen quality systems, and drive continuous improvement. With continued growth in our medical device portfolio and pharmaceutical manufacturing operations, you'll have the opportunity to expand your leadership capabilities while making a meaningful impact on quality performance and operational excellence. A Day in the Life: You will lead a team of approximately 3–4 direct reports responsible for supporting deviation, Corrective and Preventive Action (CAPA), and complaints management programs across the Greenville site. Your responsibilities will include providing oversight of quality investigations, monitoring program performance, ensuring timely CAPA execution, and identifying opportunities to improve quality processes. You'll work closely with Quality, Manufacturing, Operations, and other cross-functional partners to resolve complex quality issues, maintain inspection readiness, and support effective risk-based decision-making. As a people leader, you'll coach and develop your team, establish priorities, and foster a collaborative, accountable environment. This role offers broad exposure to multiple client products and portfolios, including expanding medical device operations. What to expect: • Provide leadership and oversight of the Deviation, CAPA, and Complaints programs, ensuring compliance with cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and applicable quality system requirements. • Lead and develop a team of quality professionals, providing coaching, performance guidance, and support for professional growth. • Oversee deviation investigations, root cause analysis, CAPA development, implementation, and effectiveness checks to ensure timely and sustainable resolution of quality issues. • Monitor quality metrics, identify recurring trends, facilitate governance reviews, and communicate program performance and significant quality concerns to leadership. • Collaborate with cross-functional stakeholders to resolve quality challenges, improve investigation effectiveness, and drive continuous improvement initiatives. • Support internal and external audits, client inspections, and regulatory inspections as a subject matter expert for deviation and CAPA management. • Maintain effective quality documentation, procedures, and electronic quality management system records while supporting training and process improvements. • Establish priorities, manage competing business needs, and support quality systems across pharmaceutical and medical device products. Keys to Success: Education Bachelor's degree in a scientific, engineering, health-related, or closely related technical field. Experience • Minimum of 7 years of experience in the pharmaceutical or medical device industry, including investigations, deviation management, CAPA, Quality Assurance, or related quality systems responsibilities. • Minimum of 5 years of leadership experience with direct reports, including employee development, coaching, and performance management. • Demonstrated experience overseeing deviation investigations, CAPA implementation, effectiveness checks, and complaints management within a regulated environment. • Strong understanding of FDA regulatory requirements, cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and pharmaceutical quality systems. • Experience using electronic quality management systems such as TrackWise, Veeva Vault, MasterControl, or similar platforms. • Excellent analytical, investigation, and problem-solving skills with the ability to identify root causes and implement effective corrective actions. • Strong communication, interpersonal, and stakeholder management skills with the ability to influence and collaborate across organizational levels. • Proven ability to lead cross-functional initiatives, manage competing priorities, and deliver results within established timelines. • Experience with quality metrics, trend analysis, risk management, inspection readiness, and continuous improvement. • Strong organizational skills, attention to detail, and demonstrated ability to develop high-performing teams. • Experience supporting pharmaceutical manufacturing and medical device quality systems is highly desirable. • Physical requirements include the ability to work in an office and manufacturing environment, stand or walk for extended periods as needed, and occasionally lift up to 25 lbs.
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Full TimeVia Partner
AU
AIRCRAFT FLIGHT INSTRUCTOR (CH-47)
HQI 83
Greenville, South Carolina$131,841–$171,396/yr1d ago
THIS IS A NATIONAL GUARD TITLE 32 EXCEPTED SERVICE POSITION OPEN TO THE FOLLOWING AREA OF CONSIDERATION (AOC): Area of Consideration: This position is open to ALL areas. Area 1: Current employees of the South Carolina Army National Guard (Tenure 1 and 2) Area 2: Current members of the South Carolina Army National Guard Area 3: Any individual eligible for membership in the South Carolina Army National Guard *Temporary and Indefinite employees do not meet permanent tenure requirements and are not eligible for Area 1. MINIMUM EXPERIENCE REQUIREMENTS: An applicant must have a competent understanding of the occupation's basic principles and concepts. Applicants should have a minimum of one year on-the-job experience in the grade (or a comparable military rank) immediately below the next higher level. SPECIALIZED EXPERIENCE REQUIREMENTS: Is experience that prepares the applicant to perform the Dual Status technician duties and responsibilities. To qualify, an applicant's educational-degree study program, military professional and technical training schools or academies, and aviation certifications may apply as substitutions for some specialized experience factors. OTHER QUALIFICATION REQUIREMENTS: 1. Prior to appointment, an applicant's military medical record must indicate a completed and current medical physical, flight physical, medical profile, and completed/cleared drug test. 2. Possess a valid state driver's license to operate government motor vehicles, for the state in which they live or are principally employed, in accordance with Army and Air Force Vehicle Operations Directives; and, 3. Qualify to operate government motor vehicles and vehicular equipment for "Maintenance Purposes Only" according to Army or Air Force Vehicle Maintenance Operations Directives. Applicants must have the following: 1. Must have the appropriate security clearance: a. In regard to the aviator position's Series GS 2181 and the DoD criteria for the technician position's compatible military skill classification security clearance requirements. NOTE: Refer to the military services' specific classification directives for the military skills' required security clearance levels; OR b. Awarded a current Single Scope Background Investigation according to Army or Air Force Personnel Security Program Management Directives. Award of entry level to the technician position's compatible military skill, without a completed SSBI, is authorized provided an interim Top Secret security clearance was granted. NOTE: Refer to the military service specific directives for various authorized interim clearance levels. 2. No record of claustrophobia or claustrophobic tendencies. 3. To maintain the position - The incumbent must have a current Network License according to Army or Air Force Directives, Licensing Network Users and Certifying Network Professionals. CONDITIONS OF EMPLOYMENT & NOTES: 1. This is an Army National Guard dual status technician position which requires military membership. 2. Incumbent is subject to uncommon tours of duty, rotational shift assignments and compensation and/or overtime duty. 3. Must be able to obtain and maintain the appropriate security clearance of the position. 4. This position is covered by the Domestic Violence Misdemeanor Amendment (30 Sep 96) of the Gun Control Act (Lautenberg Amendment) of 1968. An individual convicted of a qualifying crime of domestic violence may not perform the duties of this position. 5. The employee may be required to travel in military and/or commercial aircraft to perform temporary duty assignments. 6. This is a Testing Designated Position (TOP). The employee is subject to random drug testing. Preemployment drug testing and participation in random drug testing is a condition of employment. Note: The caveat is that the states, territories, and the district cannot drug test until a drug free workplace policy has been established and approved by the United States Department of Health and Human Services. 7. Incumbent must possess and continue to maintain a US Army Class II Flight Physical. 8. Employee will be required to wear and use personal protective equipment as required and provided by the employer. This position is located in the Training Operations Branch of an Army National Guard Army Aviation Support Facility (AASF). The position is responsible for providing instruction, evaluation and examination of rated pilots, instructor pilots and aeroscout observers in flying techniques and methods of instruction, examination and evaluation. Instruction involves basic and advanced techniques for flying aircraft using instruments. Positions in this series involve piloting or co-piloting aircraft to carry out various operational programs and functions of the Army and Air National Guard. The work provides ground and flight instruction and evaluation in aircraft piloting. The positions perform staff work concerned with planning, analyzing, or administering agency specific aviation programs, where the work requires primarily the application of pilot knowledge and skills. The Series encompasses all functions performed by rated pilots to conduct or directly support flying operations and training missions. Inherently included in this Series are supervisory and staff functions such as commanding, inspection, contingency planning, and policy formulation. The career area encompasses utilization fields that directly employ weapons and supporting weapon systems to accomplish the Army National Guard and Air National Guard operational missions. It encompasses flying operations and non-operational aviation positions concerned with the employment and support of aviation units and elements. This Series directs and coordinates the employment of aviation units in support of land combat operations. It provides expertise at all levels of command to develop doctrines and plans essential to the successful employment and deployment of aviation systems. Included in this Series are Operations Commanders, Pilots, Combat Systems Officers, Remotely Piloted Aircraft Pilots, Special Tactics, Combat Rescue, Space, Nuclear and Missile Operations, Maintenance Test Pilots, Cyber Operations, Operations Security, and Operations Support.
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Full TimeVia Partner
TS
Senior Operational Excellence and Digital Specialist
HQI 83
Greenville, North Carolina, USA2d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Senior Operational Excellence and Digital Specialist Drug Product Division (DPD) | Greenville, North Carolina As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Discover Impactful Work As a Senior PPI Business System Specialist, you will deliver measurable improvements at our Greenville pharmaceutical manufacturing site through the Practical Process Improvement (PPI) Business System and DPD One Way, the Drug Product Division approach to consistent operating practices. This hands-on role combines manufacturing-floor problem solving, independent project delivery and team coaching. You will translate site priorities into sustained improvements in throughput, overall equipment effectiveness (OEE), right-first-time performance, deviation reduction, cycle time, service and cost of goods sold, while protecting safety and compliance. A Day in the Life · Build a prioritized pipeline of site PPI and digital opportunities for your assigned area, aligned with site annual operating plans and DPD priorities. Observe processes, identify constraints and develop project/initiative charters using divisional templates, with clear scope, owners, baselines and success criteria. · Deploy and sustain DPD One Way visual management, Tier 1 and Tier 2 daily accountability, KPI reviews, escalation routines and leader standard work. Coach and train teams in daily tier accountability and independently apply KPI management and frontline coaching. · Use A3 problem solving, Six Sigma DMAIC, root-cause analysis and structured experimentation to address losses and variation. Apply statistical process control (SPC) and process capability analysis, including Cpk, using Minitab or equivalent tools within approved procedures. · Partner with Operations, Quality, Engineering, Maintenance, Tech Transfer and Supply Chain to remove constraints. Work with sterile process experts on production line losses, aseptic interventions, contamination risks and batch-release delays, supporting deviation and CAPA investigations as appropriate. · Facilitate Kaizen events and independently apply value stream and process mapping, Gemba observation, 5S, the eight wastes, standard work, level loading and material flow. Improve OEE through quick changeover, setup preparation, mistake proofing and maintenance diagnostics with total productive maintenance (TPM). · Lead assigned initiatives from charter through implementation, stabilization and sustainment. Manage schedules, resources and dependencies; maintain risks, assumptions, issues and decisions; and escalate barriers with mitigation options and clear requests for decisions. Ensure applicable change controls, procedure updates, training and validation are completed before implementation. · Coach operators, team leaders and managers at the point of work. Assess stakeholder and training needs, communicate changes and verify adoption. Incorporate approved standard work, centerlines and critical process parameters into daily routines, sharing proven practices across the PPI network. · Support business cases with Finance and process owners, defining assumptions, measurement methods and benefit owners. Document baselines, implementation, stabilization and sustained benefits; provide accurate KPI and Finance-validated savings inputs to monthly site and divisional reviews. · Support approved digital solutions for operational performance. Independently map digital processes, identify use cases and work with digital specialists on analytics, connected shop-floor tools and collaboration. Confirm data readiness and consistent KPI definitions, and support onboarding and user adoption. · Verify that improvements remain effective after project closure through adoption measures, clear process ownership and follow-up performance reviews. Embed solutions into tier routines and standard work to prevent one-off gains. What to Expect · A primarily onsite role in Greenville, North Carolina, with regular manufacturing-floor engagement and hands-on work with operating teams. · Collaboration with line and functional leaders, aligned with DPD PPI and Digital standards. The immediate focus is site execution, with opportunities to support broader deployment and coaching as needs evolve. · Travel of 0–15% as business needs require. · Work in a GMP manufacturing environment, following applicable safety, gowning, contamination-control and site procedures. Keys to Success Education · A bachelor’s degree with approximately 8 years of relevant experience, or an advanced degree with approximately 6 years, is preferred. · Engineering, Science, Operations, Business or related disciplines are preferred. Equivalent combinations of education, experience and demonstrated capability will be considered. Experience · Lean Six Sigma Black Belt certification is required, supported by a multi-year track record of delivering Kaizen improvements and DMAIC projects with measurable, sustained operational and financial results. · Demonstrated success delivering hands-on Lean, Six Sigma or operational excellence improvements in operations, with measurable operational and financial results sustained after implementation. · Experience working directly with operators and supervisors to improve daily management and standard work, with the ability to contribute quickly in a complex, fast-paced operating environment. · Sterile pharmaceutical manufacturing experience is strongly preferred. Relevant experience in pharma, other regulated manufacturing or similarly complex operations will also be considered. · Practical experience leading statistical analyses, including SPC and process capability, and translating findings into effective countermeasures. · Experience leading cross-functional projects through implementation and sustained adoption, including planning, risk management, benefits tracking and team coaching. Project management certification is a plus. · Familiarity with change management approaches such as Prosci or Kotter and Agile fundamentals is preferred; relevant certification is advantageous. Knowledge Skills and Abilities · Ability to connect shop-floor observations and data to a clear problem statement, verified causes and effective countermeasures. · Operational credibility, constructive conflict management and the ability to influence without direct authority, role-model effective leadership and build ownership with frontline teams. · Strong facilitation, coaching and communication skills in English, with the ability to explain technical findings clearly and collaborate across functions. · Working knowledge of strategy deployment, business and financial performance, and project time and scope management; ability to prioritize work and validate benefits with Finance. · Ability to improve processes while respecting quality, patient safety and regulatory requirements. · Proficiency in Excel and PowerPoint and practical familiarity with operations systems and digital tools, including Power BI, MES, CMMS, eQMS, digital performance management, and collaboration platforms. · Practical experience using approved AI tools such as ChatGPT to create agents and reusable workflows for operational analysis, problem solving and productivity.
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Full TimeVia Partner
TS
Quality Specialist II - Complaints
HQI 83
Greenville, North Carolina, USA2d ago
Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer. REQUIREMENTS: • Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment • Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field • Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements • Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent) • Experience in deviation investigations, CAPA, change control, and root cause analysis • Proficient in Microsoft Office suite and quality management software systems • Technical writing and documentation skills • Analytical and problem-solving abilities • Clear verbal and written communication skills • Ability to work independently and collaboratively in cross-functional teams • Proactive and capable of managing multiple tasks and meeting deadlines in a fast-paced environment with minimal supervision. • Experience conducting internal audits and supporting external regulatory inspections • Project management and organizational skills • Ability to work in cleanroom environments and follow gowning procedures where required • Additional language skills may be beneficial • Up to 10% travel may be required • Must be able to work various shifts to support manufacturing operations • Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
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Full TimeVia Partner
TS
R&D / Mfg Scientist III (MSAT Tech Transfer)
HQI 81
Greenville, North Carolina, USA2d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Role Overview Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work. Discover Impactful Work! • Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. • Leads technical/scientific process/product/project activities to implement strategies and technical solutions. • Drives creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients. • Makes decisions that involve direct application of technical knowledge. A Day in the Life. • Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation. • Represent the organization on formal technical and scientific forums. • Lead and/or participate in problem solving and project work for formulations, equipment and processes. • Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required. • Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points. • Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs. • Assess material changes and determine change impact. • Support development of proposals and timelines for projects, leading relevant client meetings. • Review new bid quotes, protocols, technical documents, results, and reports. Keys to Success Education: • Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. Experience: • Bachelors and 3+ years confirmed experience • CMO or Pharmaceutical product development experience PREFERRED Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: • Advanced knowledge of variety of aspects of a subject area and working knowledge of principles and concepts in other relevant technical subject areas. • Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry. • Detailed knowledge of Good Manufacturing Practices. • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. • Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients. • Ability to work on multiple projects simultaneously. • Proficiency at developing knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. • Capability to keep current with scientific literature and industry trends relating to process technologies. • Ability to develop technical solutions. • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
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Full TimeVia Partner
Senior Cost Manager - Life Sciences Construction
HQI 83
Greenville, North Carolina, us2d ago
Company Description Turner & Townsend is a global professional services company with over 22,000 people in more than 60 countries.  Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes that improve people’s lives. Working in partnership makes it possible to deliver the world’s most impactful projects and programs as we turn challenge into opportunity and complexity into success.  Our capabilities include program, project, cost, asset and commercial management, controls and performance, procurement and supply chain, net zero and digital solutions.  We are majority-owned by CBRE Group, Inc., the world’s largest commercial real estate services and investment firm, with our partners holding a significant minority interest. Turner & Townsend and CBRE work together to provide clients with the premier program, project and cost management offering in markets around the world.  Job Description Turner & Townsend are seeking an experienced Senior Cost Manager and/or Quantity Surveyor to serve as a key day-to-day client interface, ensuring client objectives are achieved through the delivery of value-added cost management services. This position will support a major pharmaceutical and consumer health manufacturing expansion program in Wilson, North Carolina, approximately 40 miles southwest of Greenville. The program involves the redevelopment and expansion of a large-scale manufacturing campus. The successful candidate will play an integral role in delivering cost management services throughout the full project lifecycle, from planning and design through construction and closeout. To be successful in this role, you must have excellent communication skills and be comfortable operating in a client-facing environment. The ideal candidate will be self-motivated, driven, and capable of working independently while collaborating effectively as part of a team. In this significant position, you will provide leadership and direction while promoting the purpose, values, and vision of Turner & Townsend. Responsibilities: • Estimating and negotiating change orders throughout the construction lifecycle. • Provide estimate and cost planning services, including producing and presenting final cost plans. • Review and participate with the design services team and general contractor in the development of cost estimates. • Reconcile changes and assist the general contractor to ensure cost data is accurate. • Communicate and meet with the general contractor, owner, and project manager to gather status information and prepare cost estimate updates. • Prepare written comments on contractor submissions, including executive summaries. • Coordinate all sources of cost information for cost discussions, including suppliers, subcontractors, NPA data, quantities, and A/E information. • Inform and drive engineering priorities based on cost impacts. • Work proactively with minimal supervision to resolve project and scheduling issues. • Manage cost checks and carry out valuations on larger projects while ensuring timely and accurate cost validation. • Participate effectively in post-contract cost variance management and change control processes. • Manage cost impact assessments, contingency management, and commitment tracking logs. • Prepare funding presentations and coordinate value engineering sessions with stakeholders. • Develop cost plans and estimates throughout the design phase, providing updates at key design milestones. • Provide commercial input into design optioneering and value engineering exercises. • Review contractor and subcontractor pricing and lead negotiations on behalf of the client to secure fair and competitive contract pricing. • Perform quantity surveying, cost controls, and change management activities throughout the project lifecycle. • Ensure post-contract cost variances and change control processes are managed effectively. • Ensure robust cost auditing, valuation, and validation processes are maintained. • Produce and present monthly cost reports to the client. • Negotiate and finalize project accounts in a timely manner. • Compile and maintain built-cost benchmarking data. • Identify, coach, and mentor talent while celebrating the success of others. • Demonstrate excellence in leadership and service delivery in line with project and client expectations. • Utilize internal systems to manage commission financial performance, including fee forecasts, resource forecasting, and reporting. • Implement and maintain Turner & Townsend business management systems, methodologies, and tools to ensure consistent delivery for clients. • Be a role model who promotes a one-business culture that balances positive outcomes for our people, clients, stakeholders, and society. • SOX control responsibilities may form part of this role and must be adhered to where applicable.   Qualifications   • Bachelor's degree in Construction Management, Cost Management, Quantity Surveying, Engineering, or a related construction field. • Minimum 5-7 years of relevant experience in a cost management role within the construction industry. • RICS accredited or actively working toward accreditation preferred. • Experience leading cost management services on medium to large-scale construction projects of moderate to high complexity. • Experience leading cost management services on large-scale industrial, pharmaceutical, life sciences, manufacturing, or consumer products capital projects is strongly preferred. • Experience supporting greenfield, brownfield, expansion, or facility modernization programs is highly desirable. • Construction consultancy experience is strongly preferred. • Strong understanding of construction industry technical matters, including procurement strategies, value management, and value engineering. • Demonstrated experience managing project budgets, cost controls, change management, and commercial negotiations. • Excellent client-facing, communication, and stakeholder management skills. • Ability to work effectively in a fast-paced project environment and collaborate across multidisciplinary teams. Additional Information *On-site presence and requirements may change depending on our clients' needs.* Our inspired people share our vision and mission. We provide a great place to work, where each person has the opportunity and voice to affect change. We want our people to succeed both in work and life. To support this we promote a healthy, productive and flexible working environment that respects work-life balance.  Turner & Townsend is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and actively encourage applications from all sectors of the community. Please find out more about us at  www.turnerandtownsend.com/ Turner & Townsend does not accept any speculative or unsolicited CV’s that have been sent to our internal recruitment team or hiring managers from agencies outside of our preferred supplier list or that have not followed due process. Any speculative or unsolicited CV’s will be treated as a direct application. All your information will be kept confidential according to EEO guidelines.   #LI-MK3 Join our social media conversations for more information about Turner & Townsend and our exciting future projects:  Twitter Instagram LinkedIn It is strictly against Turner & Townsend policy for candidates to pay any fee in relation to our recruitment process. No recruitment agency working with Turner & Townsend will ask candidates to pay a fee at any time.  Any unsolicited resumes/CVs submitted through our website or to Turner & Townsend personal e-mail accounts, are considered property of Turner & Townsend and are not subject to payment of agency fees. In order to be an authorised Recruitment Agency/Search Firm for Turner & Townsend, there must be a formal written agreement in place and the agency must be invited, by the Recruitment Team, to submit candidates for review. 
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Full TimeVia Partner
VA
Physician (Regular Ft)-Greenville Primary Care
HQI 83
Greenville, North Carolina$220,000–$260,000/yr2d ago
To qualify for this position, you must meet the basic requirements as well as any additional requirements (if applicable) listed in the job announcement. Applicants pending the completion of training or license requirements may be referred and tentatively selected but may not be hired until all requirements are met. Currently employed physician(s) in VA who met the requirements for appointment under the previous qualification standard at the time of their initial appointment are deemed to have met the basic requirements of the occupation. Basic Requirements: United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy. Degree of doctor of medicine or an equivalent degree resulting from a course of education in allopathic medicine or osteopathic medicine. The degree must have been obtained from one of the schools approved by the Department of Veterans Affairs for the year in which the course of study was completed. Current, full and unrestricted license to practice medicine or surgery in a State, Territory, or Commonwealth of the United States, or in the District of Columbia. Residency Training: Physicians must have completed residency training, approved by the Secretary of Veterans Affairs in an accredited core specialty training program leading to eligibility for board certification. (NOTE: VA physicians involved in academic training programs may be required to be board certified for faculty status.) Approved residencies are: (1) Those approved by the accrediting bodies for graduate medical education, the Accreditation Council for Graduate Medical Education (ACGME) or American Osteopathic Association (AOA), in the list published for the year the residency, or fellowship if applicable, was completed; OR (2) One year of post medical school training (internship, first year of residency, or transitional year residency) approved by ACGME or AOA followed by two years of post-training independent practice (performing under a full and unrestricted license) in the United States; OR (3) Non-US residency training programs followed by a minimum of three years of verified independent practice in the United States (performing under a full and unrestricted license) performing duties related to the position they are applying for (United States fellowships would be creditable towards this requirement), which the local Medical Staff Executive Committee deems to have provided the applicant with appropriate professional training and believes has exposed the Physician to an appropriate range of patient care experiences. Exceptions: Residents currently enrolled in ACGME/AOA accredited residency training programs and who would otherwise meet the basic requirements for appointment are eligible to be appointed as "Physician Resident Providers" (PRPs). PRPs must be fully licensed physicians (i.e., not a training license) and may only be appointed on an intermittent basis. PRPs are not considered independent practitioners and will not be privileged; rather, they are to have a "scope of practice" that allows them to perform certain restricted duties under supervision. Additionally, surgery residents in gap years may also be appointed as PRPs. In rare and unusual circumstances, the Facility Director can submit a memo to the VISN Director through the VISN Chief Medical Officer, who may approve requests for reasonable exceptions to the residency training requirement for Physicians whose composite record of experience, accomplishments, performance, and qualifications warrant such action. Proficiency in spoken and written English. Preferred Experience: Internal Medicine or Family Medicine Physicians with outpatient Primary Care clinical experience. Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/. Physical Requirements: Work is primarily sedentary in an outpatient clinical setting with periods of standing, walking, bending, reaching, and computer use associated with direct patient care and documentation. The physician must possess sufficient mobility, dexterity, visual and hearing acuity, and communication skills to safely perform clinical duties, operate standard medical equipment, and provide patient care. Physical and occupational health requirements will be consistent with applicable Department of Veterans Affairs policies, including VA Directive and Handbook 5019, Employee Occupational Health Services. VA offers a comprehensive total rewards package. VHA Physician Total Rewards. Recruitment/Relocation Incentives (Sign-on Bonus): Not Auhorized Education Debt Reduction Program (Student Loan Repayment): Learn more. EDRP Authorized: Former EDRP participants ineligible to apply for incentive. Contact Byron Collins, Byron.Collins@va.gov, the EDRP Coordinator for questions/assistance. Telework Eligible: Ad-hoc per agency policy. Pay: Competitive salary, annual performance bonus, regular salary increases Paid Time Off: 50-55 days of paid time off per year (26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year and possible 5 day paid absence for CME) Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement) Licensure: 1 full and unrestricted license from any US State or territory CME: Possible $1,000 per year reimbursement (must be full-time with board certification) Malpractice: Free liability protection with tail coverage provided Contract: No Physician Employment Contract and no significant restriction on moonlighting Work Schedule: 8:00am-4:30pm Clinical: Primary focus of practice is the independent clinical evaluation of Veterans through their panel of patients including prevention and patient self -management. Comprehensive primary care will be provided to male and female Veterans. Comprehensive primary care includes but is not limited to evaluating patients in an outpatient clinical setting to diagnose and treat acute and or chronic diseases, educating on health promotion and disease prevention and ensuring that health maintenance is up to date. Completes physical examinations, which maybe comprehensive, focused or gender specific to formulate treatment plans. Treatment plans are evidence based and engages in shared medical decision making of treatment plans. Maintains clinical knowledge and skills to provide comprehensive primary care services to male and female patients. Care may be provided in many modalities, from direct face to face care, virtual care (including telephonic, video, secured messaging and others) Promotes, directs, evaluates and is responsible for referrals of clinical concerns that are found during these evaluations. Functions as a member of a Patient Aligned Care Team, collaborating with clinical and administrative support to provide timely, quality, coordinated care for Veterans. Utilizes and promotes approved standards of care, procedures, methods and techniques, safety precautions and protocols in their application to this population in all settings. Collaborates with other health care resources to ensure continuity of care. Keeps abreast of latest trends, skills, procedures, and protocols relevant to primary care and serves as a resource person for the medical center staff. Participates in continuous medical education as per requirements with topics included but not limited to opioid prescribing and trainings to fulfill and maintain designated women's health primary care provider. May provide coverage for other providers in clinic or other primary care clinics if needed or assigned. Exemplifies the ICARE core values of-Integrity, Commitment, Advocacy, Respect, and Excellence. Administrative: Assists with arranging continuity of care across the VHA system as needed. Works to provide team leadership on site to ensure care is completed in required timeframes. Participates in Quality Improvement activities. Participates and attends medical center committees as assigned by the Associate Chief of Staff (ACOS) Ambulatory Care Service.
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Full TimeVia Partner
TS
Sr. Material Handler (8hr 1st shift, Mon-Fri)
HQI 81
Greenville, North Carolina, USA3d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. Shift hours are 8hr 1st shift, Monday-Friday. How Will You Make an Impact?: The Sr. Material Handler supports Supply Chain team with internal Logistics including movement and management of cold storage trailers. This includes safe, compliant, efficient, accurate receipt, storage, movement / picking of materials for Warehouse Operations Customers. Completes all inventory transaction, cycle counting as necessary and as advised by departmental supervision. Provides effective, efficient and accurate preparation, assembly shipment documentation of orders for internal and external customers. Cross trains in the three warehouse areas designated by supervision. A Day in the Life • Receiving, examining, sorting, arranging, counting, storing, picking, and packing items for storage and/or shipment in accordance with established procedures and customer requirements. • Preparing and filing routine documentation. • Maintaining quality metrics. • Operating material handling equipment (e.g. hand truck, pallet jack, Forklift etc). • Ensure all controlled substances are handled according to procedures. • Ensure all hazardous materials are handled safely per regulations and procedures. • Ability to assist on the job (OTJ) training as needed.Assist with physical inventory/cycle counting of the warehouse as required. • Address Inventory discrepancies, Reprint labels, adjust inventory as needed, and maintains research history trail • Leads troubleshooting ideas and leads change amongst team. • Assists with internal and external audits of warehouse. • Acts as liaison with internal customers to schedule and manage freight/logistics companies for deliveries/shipments. • Assists with leadership, direction, communication and facilitates teamwork within the warehouse operations group. • Conducts work in a safe and effective manner, following all applicable procedures and policies in accordance with Current Good Manufacturing Practices (CGMP’s), taking appropriate action to correct unsafe acts, systems and procedures. Education: • High school diploma or equivalent required. Experience: • Required: Minimum of 2 years of work experience in distribution, warehouse or supply chain or related field. • Preferred: CDL license • Preferred: Experience with powered industrial trucks (order pickers, forklifts) • Preferred: Experience in a cGMP environment Knowledge, Skills, Abilities • Self Starter, leading team activities • Ability to lead with respect for others • Intermediate math skills. • Basic computer knowledge to navigate company systems (i.e. workday, SAP, iMost) • Advanced verbal/written communication. • Ability to work independently and effectively • Attention to detail while maintaining a quality product. • Ability to perform repetitive work duties. • Ability to follow SOPs. Physical Requirements/Work Environment • Use Personal Protective Equipment (PPE) and understand chemical hygiene. • Infrequently lift and manipulate up to 50 pounds max unassisted. • Stand and move about including reaching, bending, stooping, grasping. • Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.
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Full TimeVia Partner
District Sales Manager (MEP Channel) - Western Carolinas - Diablo Tools
HQI 81
Greenville, SC, us3d ago
Company Description THE BEST NEED THE BEST. Known as "The Game Changers”, Diablo Tools ( www.DiabloTools.com ) elevates the market by providing  Best in the World  and  Best for Our World  cutting tool and power tool accessory solutions for professional users. With innovation at the forefront of everything we do, Diablo Tools continues to “raise the bar” by bringing the most advanced technology to the portable tool market that increases quality and performance and saves our users time and money. Diablo Tools is committed to providing first-class technology that makes dominates the jobsite but also makes it safer. Our innovation, however, is not the only thing that sets us apart from the competition – our people do, too. At Diablo Tools, we pride ourselves on putting “People First.” We cannot be the Best without the Best. That’s why we onboard the Best talent and continue to invest in them through ongoing training and recurring professional development opportunities. We are proud to provide a culture that is innovative, supportive, fun, connected, and nurtures growth for our people. Our commitment to our employees has been recognized by the employee engagement platform, Energage, by naming Diablo Tools a Top Workplace in 2024. Additionally, Diablo Tools was named a Top Workplace in the cultural excellence category for professional development, employee well-being and employee appreciation. We strive to be the best for our end-users and the best for our team – so  Join the Best, today! Job Description We are expanding our  MEP Sales Team  (Mechanical, Electrical & Plumbing) and are looking for an  extroverted,   highly motivated, and driven sales professional.  This is an amazing opportunity to take your competitive fire and win with THE BEST. Our future-forward approach in everything we do is what separates us from the rest. We Lead, Never Follow. Primary responsibility is to gain 100% market share within your categories, channels and markets and to implement strategic approaches to deliver monthly, quarterly and yearly sales numbers.  Territory includes all of Western North and South Carolina • Effectively develop programs and sales strategies for Key dealers within assigned territory with the purpose to convert, promote and consolidate key categories to Freud / Diablo. Plan for monthly, quarterly and yearly growth while staying within T&E Budget • Administrative responsibilities include scheduling, placing orders, developing presentations, suggested orders, and other administrative duties that contributes to a collaborative approach to growing the territory’s market share and sales volume. • Build sustainable territory to achieve assigned goals and metrics outlined by your manager • 50-75% Overnight Travel Qualifications • Bachelor's Degree in Business/Marketing or related field required or have 8 years of commensurate experience. • Proven effective communication with corporate staff, sales organization & customers. • Basic understanding of sales strategies, processes and approaches. • Bilingual- English/Spanish highly desired for this role. • Intermediate computer proficiency in MS Office (Word, PowerPoint, Excel, Teams, etc). Are you hungry, ready for immediate impact, excited for a challenge? Change your future forever by joining the Best! Additional Information Diablo Tools Inc. is committed to putting “People First”. We offer a comprehensive benefits package that includes health, dental, and vision plans; health savings accounts (HSA); flexible spending accounts; 401(K) retirement plan with an generous employer match; wellness programs; life insurance; short- and long-term disability insurance; paid time off; parental leave, adoption assistance; and reimbursement of education expenses. Diablo Tools and the Robert Bosch Tool Corporation are proud supporters of STEM (Science, Technology, Engineering & Mathematics) Initiatives • FIRST Robotics  (For Inspiration and Recognition of Science and Technology) • AWIM  (A World In Motion) Equal Opportunity Employer, including disability / veterans Indefinite U.S. Work authorized individuals only.  Future sponsorship for work authorization unavailable. Safety Sensitive Position #LI-ML1
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Full TimeVia Partner
TS
Senior Manager, QC Analytical Development
HQI 76
Greenville, North Carolina, USA4d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. GROUP/DIVISION SUMMARY The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 10,000 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. POSITION SUMMARY The Sr. Manager, QC Analytical Development, leads all aspects of the staff and operations of the Analytical Development Laboratory unit, providing strategic direction and leadership. This role establishes and implements quality policies for materials, products, and the production environment, and participates as a key member of the site's Management Team. The Sr. Manager provides technical and operational leadership for laboratory operations and technical assistance to manufacturing facilities. Key Responsibilities: · Provide leadership by driving organizational change, empowering staff, cultivating relationships, building effective teams, fostering engagement, and supporting staff in achieving both personal career goals and organizational objectives. · Lead chemical Analytical Developmental and method transfer activities for New Business Development projects, and enhance analytical methods as required. · Assess technical responses to regulatory agencies (e.g., FDA and USP), advise Manufacturing/Quality Operations Division and VP of Operations on analytical chemistry, review regulatory submissions while negotiating analytical support for product revisions and new product introductions. · Develop and monitor capital equipment and operating budgets, and engage in both short-term and long-range planning for the Lab Services Department. · Maintain an injury-free and incident-free workspace while aligning with all job-related safety and training requirements. Qualifications: · BS/BA in Chemistry or related scientific field required. Equivalent combinations of education, training, and relevant work experience may be considered. · 10+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience required. · 7+ years in a leadership role, committed to employee engagement and development required. · Outstanding attention to detail and organizational skills. · Capable of excelling in a fast-paced environment, adept at multitasking. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. · Requires discretion and independent judgment. · Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. · Highly effective verbal and written communication skills. Proficiency in Microsoft Suite (Word, Excel, PowerPoint). · Superior cGMP experience and leadership required. · Knowledge of quality control statistics, documentation and adherence to SOP’s. · Upholds Data Integrity and cGMP standards. High attention to detail. · Makes safety a priority · Adaptable to changing product release priorities, flexible and structured communication skills. Ability to delegate. · Knowledge of Microbial test methods including Bacterial Endotoxin and Sterility testing. Particulate Matter testing a plus. · Ability to write quality technical reports and give effective oral presentations. · Ability to effectively collaborate with others to achieve team goals and expectations. · A genuine interest in researching and implementation of new approaches to analysis. PHYSICAL REQUIREMENTS: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
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Full TimeVia Partner
TS
Formulation Technician II (12hr days or 12hr nights; 2-2-3 rotation schedule)
HQI 83
Greenville, North Carolina, USA4d ago
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: Greenville, NC/DPD How Will You Make an Impact?: As a Formulation Technician II, you will play a vital role in producing sterile injectables and working on moderate-scale problems that require analysis and critical thinking. You will follow written and verbal instructions to ensure that pharmaceutical products are manufactured in accordance with industry guidelines and regulations. Night and day full time shifts available. Shift hours are 6pm-6am or 6am-6pm on a 2-2-3 rotating schedule. A Day in the Life: • Ensure pharmaceutical products are manufactured in strict accordance with area SOPs and current cGMP. • Verify and document production activities in batch records, logbooks, and controlled forms. • Complete tasks vital to manufacturing drug products in an aseptic filling area, including cleaning cGMP areas, performing line changeovers, parts preparation, filter integrity testing, operating parts washers and autoclaves, performing tray loading and unloading, operating the filling isolator, and general material handling. • Troubleshoot equipment alarms. Education: High school diploma or equivalent required. Experience: Required: Minimum of 1 year of work experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities: • Ability to excel in a team environment, follow standard operating procedures, and perform repetitive work duties • Basic math skills. • Good verbal/written communication. • Attention to detail while maintaining a quality product. Physical Requirements / Work Environment • Work in a clean-room environment with controlled temperature, humidity, and low ambient noise. • Wear appropriate gowning and personal protective equipment. • Infrequently lift and manipulate up to 50 pounds unassisted. • Stand and move about, including reaching, bending, stooping, grasping. • Use hand tools and equipment
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Full TimeVia Partner
TS
Material Handler II (8hr or 12hr shifts; nights or days)
HQI 83
Greenville, North Carolina, USA4d ago
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. Depending on the team, shifts will be 6pm-6am or 6am-6pm on a 2-2-3 rotating schedule, or an 8hr shift Monday-Friday. How Will You Make an Impact?: The Material Handler II provides safe, compliant, efficient, accurate receipt, storage, movement / picking of materials for Warehouse Operations Customers. Completes all inventory transaction, cycle counting as necessary and as directed by departmental supervision. Provides effective, efficient and accurate preparation, assembly shipment documentation of orders for internal and external customers. Cross trains in the three warehouse areas designated by supervision. A Day in the Life: • Receiving, examining, sorting, arranging, counting, storing, picking, and packing items for storage and/or shipment per the established procedures and customer requirements. • Preparing and filing routine documentation. • Maintaining quality metrics. • Operating material handling equipment (e.g. hand truck, pallet jack, Forklift etc). • Ensure all controlled substances are handled according to procedures. • Ensure all hazardous materials are handled safely per regulations and procedures. • Ability to assist on the job (OTJ) training as needed. • Assist with physical inventory/cycle counting of the warehouse as required. • Address Inventory discrepancies • Troubleshoots issues related to receiving, inventory, and shipping documents. • Conducts work in a safe and effective manner, following all applicable procedures and policies in accordance with Current Good Manufacturing Practices (CGMP’s), taking appropriate action to correct unsafe acts, systems and procedures. Education: • High school diploma or equivalent required. • Equivalent combinations of education, training and relevant work experience may be considered. Experience: Required: • Minimum of 1 year of work experience in distribution, warehouse or supply chain or related field Preferred: • Experience in a cGMP environment • Experience in warehouse/manufacturing operations or supply chain management Experience with Inventory Control and/or with a life science company is a plus. • Forklift / power jack experience strongly preferred Knowledge, Skills, Abilities: • Excels in a team environment. • Intermediate math skills. • Basic computer knowledge to navigate company systems (i.e. workday, SAP, iMost) • Good verbal/written communication. • Ability to work independently and effectively • Attention to detail while maintaining a quality product. • Ability to perform repetitive work duties. • Ability to follow SOPs. Physical Requirements / Work Environment • Use Personal Protective Equipment (PPE) and understand chemical hygiene. • Infrequently lift and manipulate up to 50 pounds max unassisted. • Stand and move about including reaching, bending, stooping, grasping. • Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.
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Full TimeVia Partner
TS
Quality Specialist III
HQI 83
Greenville, North Carolina, USA5d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. POSITION SUMMARY The Quality Specialist III, provides Quality oversight in the steriles lab for processes and projects, performs compliance assessments, makes decisions regarding regulatory requirements, writes new procedures and ensures adherence to current regulations. Key Responsibilities: • Performs daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs. • Provides internal and external customer support • Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique • Fosters quality culture by aiding personnel in understanding application of policies and controls • Participates in rapid response process and provides quality guidance for deviation events • Ensures escalation of deviation events to the appropriate area and quality management • Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity • Performs quality review and approval of deviation and change control of moderate to high complexity • Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity • Performs quality batch record review process and/or batch disposition • Aids in identification of continuous improvement opportunities • Participates in practical process improvement (PPI) initiatives Qualifications: • BS/BA in a scientific or related field required. • 5+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred. • 2+ years in one or more of the following: Quality Engineering, Compliance, Regulatory Affairs. • Equivalent combinations of training and relevant work experience may be considered if at least a bachelor degree is acquired. • Previous experience in a cGMP environment. • Able to maintain focus and prioritize in a fast paced and evolving environment. • Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters. • Confirmed problem solver and effective decision maker. • Strong organizational, presentation, meeting facilitation, and technical writing skills • Excellent communication (verbal and written) skills • Outstanding attention to detail and able to work in a fast-paced environment. • Demonstrated ability to function independently and as part of a team with exceptional interpersonal skills • Strong computer proficiency skills in MS Office, TrackWise, and SAP System or equivalent • Ability to work extended hours, especially during health authority inspections, assessments, and audits PHYSICAL REQUIREMENTS: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
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Full TimeVia Partner
TS
R&D/Mfg Scientist II
HQI 83
Greenville, North Carolina, USA5d ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description POSITION SUMMARY The R&D Scientist II provides routine analyses in a chemistry and biochemistry environment within defined procedures and practices. Performs analytical methods for moderately sophisticated testing on samples, stability, and production intermediates to support process development and/or manufacturing operations. May research and implement new methods and technologies to improve operations. Makes detailed observations and reviews, documents, and communicates test results. Key Responsibilities: Lead/Execute the development, evaluation, validation and transfers of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution by HPLC, GC, IEF, CGE and compendial testing Execute testing for pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution by HPLC, GC, IEF, CGE and compendial testing Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems Determine if reported data meets specification or expected standards Demonstrate advanced knowledge and experience in Empower Demonstrate knowledge in methodvalidation/transfer/evaluation/development Perform daily instrument calibrations/verifications as required Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOP Ensure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia, GMP and data integrity requirements Might Author and/or review: OOS investigations, Deviations and Change Controls, technical reports, Protocols and validation summaries , SOPs, specification documents Ensure all job-related safety training and compliance requirements are met Might assist in trainings as an SME Communicate with Project Lead/Management concerning project status and/or concerns Strong attention to detail and organizational skills Must be able to set project priorities and time management in order to maximize productivity Actively participate in ongoing trainings and seek out opportunities to increase contributions for development of skills and responsibilities Might run projects at the broad task level under supervision, ensuring deliverables are met and next steps are clearly identified Participate in meetings/teleconferences with clients Performs all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the compliance status required by company and facility standards Qualifications: Bachelor Degree in Chemistry, Biochemistry, Molecular Biology, or related physical/biological science field minimally required with 3+ years related experience, or Master’s degree, 1+ year related pharmaceutical industry experience strongly preferred. Experience with HPLC. Experience with HPLC, GC, Dissolution, FT-IR, UV, Karl Fischer Titration, IEF, ELISA, CGE, Dot-Blot preferred Experience performing method development and validation, chemical tests with chromatographic, spectroscopic, or other analytical techniques preferred Experience with EMPOWER preferred. Equivalent combinations of education, training, and meaningful work experience will be considered. Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry Strong interpersonal and communications skills, written and oral Ability to read, analyze, and interpret technical procedures and governmental regulations. Excellent organization and planning skills. Strong attention to detail and ability to implement to standard procedures. Ability to design and complete tasks and studies based on the deliverables. Ability to accurately detail work and write reports. Fluent in English Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.
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Full TimeVia Partner
TS
QC Scientist I - Environmental Monitoring Night shift
HQI 83
Greenville, North Carolina, USA10/16/2026
Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description Location: Greenville, NC Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Excellent Benefits Package • Medical, Dental, & Vision benefits – effective Day 1 • Paid Time Off & Holidays • 401K Company Match up to 6% • Tuition Reimbursement – eligible after 90 days! • Employee Referral Bonus • Employee Discount Program • Recognition Program • Charitable Gift Matching • Company Paid Parental Leave • Career Advancement Opportunities Location/Division Specific Information Greenville, NC Hours: 6:00pm – 6:00am, 2-2-3 rotating schedule with 15% shift differential As part of the Drug Product Division (DPD), our Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development through commercialization. This position supports our sterile manufacturing operations through Environmental Monitoring activities performed within classified and aseptic processing areas. The Environmental Monitoring team works alongside manufacturing throughout the filling process to help ensure controlled environments are maintained in accordance with established procedures and regulatory requirements. How will you make an impact? As a QC Scientist I – Environmental Monitoring, you will perform Environmental Monitoring activities in support of sterile pharmaceutical filling operations. This is a hands-on role that works directly within classified manufacturing environments and is not a traditional bench laboratory position . You will collect environmental samples within filling suites, monitor controlled environments, follow aseptic practices and good documentation requirements, and accurately record and communicate results. You will work closely with Operations, Quality, and other team members to help maintain the environmental controls necessary to manufacture sterile pharmaceutical products safely and compliantly. This is an excellent opportunity to begin or grow a career within the pharmaceutical industry while gaining experience in aseptic processing, Environmental Monitoring, Good Manufacturing Practices (GMP), and sterile manufacturing operations. The hiring manager described the position as an entry point into pharmaceutical operations that can provide exposure to future opportunities across Quality, Manufacturing, data auditing, and the Environmental Monitoring organization. What will you do? • Perform routine Environmental Monitoring activities within classified cleanrooms and aseptic processing areas in support of sterile filling operations. • Collect environmental samples within manufacturing and filling suites in accordance with approved procedures. • Perform monitoring activities associated with aseptic core areas, isolator lines, and other controlled manufacturing environments. • Follow established procedures for environmental and personnel monitoring while maintaining appropriate aseptic technique. • Accurately document activities and results in accordance with Good Documentation Practices, ALCOA principles, GMP requirements, and site procedures. • Generate and record accurate, complete, legible, and contemporaneous documentation. • Review Environmental Monitoring information and communicate observations, issues, or unexpected results to the appropriate team members. • Communicate effectively with assigned manufacturing lines, supervisors, and incoming shifts to ensure appropriate handoffs and continuity of work. • Complete routine Environmental Monitoring activities performed on weekly, biweekly, monthly, and production-driven schedules. • Maintain assigned equipment and verify equipment is ready and appropriate for use. • Follow Standard Operating Procedures (SOPs), safety requirements, and established Quality procedures. • Maintain required training and qualification status for work within classified and aseptic areas. • Work both independently and collaboratively after completing the appropriate training and qualification process. • Maintain an organized work area and appropriately handle Environmental Monitoring equipment and materials. • Escalate roadblocks, incomplete activities, environmental concerns, or documentation issues to supervision as appropriate. • Perform other duties as assigned. The role requires considerable time on your feet and regular movement throughout manufacturing areas. Depending on the activity and equipment involved, employees may also be required to lift approximately 10–40 pounds. Education • Bachelor’s degree in Biology, Microbiology, or another related science field is preferred. • Associate degree in a science-related field is required. • Equivalent combinations of education, training, and relevant work experience may be considered where appropriate, provided the minimum education requirement is met. Experience This is an entry-level pharmaceutical opportunity . Previous experience in Environmental Monitoring, microbiology, pharmaceutical manufacturing, aseptic processing, cleanroom operations, or another regulated environment is preferred but not required for candidates who demonstrate the appropriate scientific foundation and ability to learn. Candidates with an associate degree and relevant pharmaceutical or Environmental Monitoring experience may also be considered. Previous experience with microbiological testing or Environmental Monitoring is particularly valuable. Knowledge, Skills and Abilities • Strong attention to detail and commitment to accurate documentation. • Ability to learn and consistently follow GMP, Good Documentation Practices, ALCOA principles, SOPs, and other regulatory requirements. • Interest in or understanding of Environmental Monitoring within a pharmaceutical manufacturing environment. • Ability to learn and apply aseptic techniques and gowning requirements. • Strong written and verbal communication skills. • Ability to communicate effectively during shift handoffs and with manufacturing, Quality, supervisors, and other colleagues. • Ability to work effectively both independently and as part of a collaborative team. • Proactive approach to completing assigned work and communicating roadblocks or concerns. • Ability to organize work and manage assigned activities in a fast-paced manufacturing environment. • Working knowledge of Microsoft Office applications and ability to accurately enter and transcribe data. • Ability to follow detailed procedures and maintain accurate, legible, and contemporaneous records. • Willingness and ability to work a 12-hour rotating night-shift schedule. Physical Requirements / Work Environment This position requires work within classified cleanroom and aseptic manufacturing environments and the ability to successfully complete applicable gowning and aseptic qualifications. The position requires extended periods of standing and walking as well as the ability to bend, reach, stoop, kneel, squat, and crouch periodically. Employees must be able to lift, carry, and move equipment and materials associated with Environmental Monitoring activities, typically weighing approximately 10–40 pounds. The role also requires sufficient hand and finger dexterity to operate equipment and computer systems, as well as visual acuity necessary to read procedures, documentation, computer displays, and equipment.
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Full TimeVia Partner
TS
Change Control and Quality Systems Specialist
HQI 83
Greenville, North Carolina, USA10/14/2026
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Excellent Benefits Package Review our company’s Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 5% Tuition Reimbursement – eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Location/Division Specific Information Greenville, NC RELOCATION ASSISTANCE IS NOT PROVIDED • Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE. • Must be able to pass a comprehensive background check, which includes a drug screen. Discover Impactful Work: This role focuses on ensuring quality and compliance within regulated environments while supporting continuous improvement and operational excellence across quality systems. A Day in the Life: You will support quality systems, manage compliance activities, participate in audits, and contribute to continuous improvement initiatives across regulated environments. What to expect: • Manage and support quality systems including CAPA, deviations, and change control • Ensure compliance with GMP/GxP regulations and ISO standards • Conduct and support internal and external audits • Develop and maintain quality documentation such as SOPs • Analyze data and report on quality metrics • Collaborate with cross-functional teams to drive improvements Keys to Success: Education Associate or Bachelor degree in Business administration, Data Science, Organizational Psychology, Life Sciences, or a closely related field and a minimum of 4 years of work experience within Quality Assurance and/or Manufacturing Experience • Minimum of 4 years of experience within pharmaceutical industry with combination products or medical device experience strongly preferred • Minimum of 2 years of combined work experience in change management, program/portfolio management, documentation, risk management, or relevant business areas within the pharmaceutical or healthcare industry • Advanced problem-solving abilities and attention to detail • Excellent verbal and written communication skills • Strong interpersonal skills with ability to collaborate across functions and levels • Proficiency with quality systems software such as TrackWise, KNEAT, Electronic Document Management Systems) • Proficient in Microsoft Office and data application tools such as Power BI and Tableau • Ability to work independently and guide cross-functional teams • Knowledge of risk assessment methodologies and continuous improvement tools • Project management experience preferred • Medical device change management experience is a plus • Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs.
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Full TimeVia Partner
TS
Sr Formulation Technician (12hr Day Shift; 2-2-3 rotation)
HQI 83
Greenville, North Carolina, USA10/13/2026
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: This position is part of the Pharma Services Group (PSG) and is located in our Greenville, NC facility. You will be working specifically on vial line 9, utilizing state-of-the-art equipment in a critical production area. The Greenville site is a key location for our pharmaceutical manufacturing operations, offering opportunities to work on cutting-edge projects in drug development and production. How Will You Make an Impact?: As a Sr Formulation Technician in the PSG, you will play a crucial role in ensuring the quality and efficiency of our pharmaceutical manufacturing processes. Your expertise will contribute directly to the production of life-saving medications and therapies. Shift hours are 6am-6pm on a 2-2-3 rotating schedule. A Day in the Life: • Operate and monitor advanced equipment on vial line 9 • Ensure compliance with cGMP regulations and company SOPs • Collaborate with cross- functional teams to optimize production processes • Troubleshoot technical issues and implement solutions Education: • High school diploma or equivalent required. • Equivalent combinations of education, training, and relevant work experience may be considered. Experience: • Required: Minimum of 2 years of work experience in a pharmaceutical manufacturing, operations, production, lab setting or related field • Preferred: Experience in a cGMP environment • Preferred: Experience working in a clean room environment • Preferred: Experience with aseptic processing and sterile drug manufacturing Knowledge, Skills, Abilities: • Strong understanding of pharmaceutical manufacturing processes • Proficiency in following SOPs and maintaining accurate documentation • Excellent attention to detail and ability to work in a highly regulated environment • Strong problem-solving and communication skills Physical Requirements / Work Environment: Must be able to stand for extended periods, lift up to 25 pounds, and work in a clean room environment. May require wearing personal protective equipment (PPE) for extended periods.
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Full TimeVia Partner
TS
Sr Manager, Audits & Inspections - Quality Systems & Compliance
HQI 83
Greenville, North Carolina, USA10/13/2026
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description A Senior Manager, Quality Systems & Compliance–Audits & Inspections is responsible for the quality oversight of the Client audit and Regulatory inspection programs. The Senior Manager will ensure expectations, and regulatory compliance to the following guidelines: 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10. The Senior Manager leads the quality compliance, manages internal and external audits, and ensures inspection readiness for regulatory agency reviews. The Senior Manager oversees cross-functional audit and inspection readiness by coordinating mock inspections and coaching subject matter experts. This role is a people leader role that manages direct reports at different organizational levels. Key Responsibilities • External Audit Preparation & Execution: Oversee scheduling, hosting, and responding to external client audits serving as the primary point of contact for prospective and existing clients requesting audits. • Inspection Readiness & Execution: Plan, execute, and manage mock and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA. • Documentation & Record retention: Ensure critical documentation is appropriately documented and stored to support client audits and regulatory inspections. • CAPA Management: Coordinate and oversee review and response to audit/inspection observations including tracking the implementation and effectiveness check of assigned corrective actions and preventive actions assigned to address compliance gaps and prevent recurring issues. • Communications: Utilize effective communication channels, tools, and resources to ensure appropriate awareness, coordination, and cross-functional support for client audits and regulatory inspections. • People Management: Lead, mentor, and coach functional and support personnel on quality matters involving the Audit & Inspection program. Ensure all personnel complete their training to maintain compliance. Encourage teamwork among personnel to enhance cross-functional skills. Minimal Requirements • Education: Bachelor's degree in a scientific, information management, engineering, or related field. • Experience: At least 7 years of supervisory or managerial experience with direct reports • Experience: At least 10 years of experience working within the pharmaceutical or medical device industry • Experience: At least 7 years of experience working in quality assurance and/or quality systems within the pharmaceutical or medical device industry. Skills: • Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10 • Excellent communication and interpersonal skills with the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels • Strong problem-solving skills with a proven track record in issue resolution • Proficient in electronic quality management systems such as Documentum, Veeva Vault, and TrackWise • Strong organizational and time management skills to meet critical business and functional timelines • Detail oriented with keen eye for identifying process improvement opportunities • Strong relationship-building skills with the ability to work effectively in team environments across all organizational levels
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Full TimeVia Partner
TS
AVI Software, Vision and Automation Systems Engineer
HQI 83
Greenville, North Carolina, USA10/12/2026
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Excellent Benefits Package Review our company’s Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 5% Tuition Reimbursement – eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Role Summary The AVI Software, Vision & Automation Systems Engineer configures, integrates, tests, and supports automated visual inspection (AVI) and industrial automation systems across their lifecycle. The role improves system performance, resolves technical issues, and supports deployments in manufacturing, laboratory, integration, and customer-site environments. Key Responsibilities • Configure, implement, test, troubleshoot, and optimize AVI software, machine-vision applications, PLC controls, automation sequences, and system interfaces. • Translate customer, inspection, and manufacturing requirements into system configurations, recipes, control logic, and technical specifications. • Analyze inspection results, image data, and equipment behavior to improve accuracy, reliability, and operational performance; lead or support root-cause analysis and corrective actions. • Support system integration, installation, commissioning, qualification, validation, upgrades, and deployment, including change testing and verification. • Provide technical support and escalation for customer, field-service, and internal engineering issues; collaborate across software, automation, electrical, mechanical, Quality, and Operations teams. • Create and maintain clear technical specifications, configuration records, procedures, test documentation, and troubleshooting guides. • Apply engineering and field feedback while following applicable quality, regulatory, cybersecurity, and change-control requirements. Education & Experience • Advanced degree plus 3 years of relevant experience, or bachelor’s degree plus 5 years of relevant experience, in engineering, automation, software, machine vision, or a related technical field. Equivalent combinations of education and experience may be considered. • Relevant experience with PLCs, industrial automation, machine vision, automated inspection, software-controlled equipment, manufacturing systems, or technical support. • Experience in regulated manufacturing, such as pharmaceutical, biotechnology, medical device, or life sciences, and with installation, commissioning, qualification, or validation is preferred. Knowledge & Skills • Strong systems thinking, analytical troubleshooting, and root-cause analysis skills across software, vision hardware, PLCs, equipment, networks, and manufacturing processes. • Working knowledge of PLC programming, control logic, sequencing, interlocks, alarms, I/O, and industrial communication protocols; machine vision and image processing experience is highly desirable. • Understanding of system testing, configuration management, requirements, and change control; familiarity with cGMP, validation, data integrity, and quality systems is preferred. • Clear technical writing, communication, organization, and collaboration skills, with the ability to work independently and across multidisciplinary teams. • Proficiency in English; additional languages are a plus. Ability to travel up to 50%, including to customer and Thermo Fisher Scientific locations, as required.