Lead QA Technician - Batch Record Review (8hr days, Monday-Friday)
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Lead QA Technician - Batch Record Review (8hr days, Monday-Friday)
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Full-time
high school, bachelor degree
Posted 8d ago
~40 hrs/week
Responsibilities
The Lead QA Technician provides independent quality oversight of GMP manufacturing operations, including aseptic processing and batch record review. They also lead deviation investigations, manage CAPA development, and mentor QA staff to ensure regulatory compliance.
Requirements
Candidates must have at least 3 years of experience in pharmaceutical quality assurance or a GMP-regulated environment. A high school diploma is required, while a bachelor's degree in a scientific discipline is preferred.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Job Description
As part of theThermoFisher Scientific team,you’lldiscover 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—such as protecting the environment, ensuring food safety, and helping to find cures for cancer.
Join our Pharma Services Group (PSG) and be part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical triallogistics, and commercial manufacturing. Biotech and biopharma companies trust us for our speed, flexibility, and quality across every phase of drug development. With global operations, we support active pharmaceutical ingredients (APIs), biologics, cell and gene therapy, viral vectors, formulation, clinical trials,logistics, commercial manufacturing, and packaging, delivering integrated solutions that help bring life-changing medicines to patients faster.
Within PSG, our Drug Product Division (DPD) supports customers in the formulation, production, and packaging of high-quality drug products. Our dedicated colleagues provide services including formulation development, process optimization, scale-up, sterile fill-finish, packaging, and labeling, ensuring efficient and compliant production of sterile injectable and oral dosage form products.
Location/Division Specific Information:
This role is based in Greenville, a site specializing in sterile injectable drug products from development through commercialization. Our Greenville colleagues prioritize product stability, patient safety, and long-term career growth, working with advanced technologies in a collaborative and supportive environment. Your career journey starts here.
Discover Impactful Work
As a Lead QA Technician, you will play a critical role in ensuring product quality and regulatory compliance within pharmaceutical manufacturing operations. As part of the Quality team, your work directly supports the production of life-changing medicines while enablingThermoFisher Scientific’s mission of making the world healthier, cleaner, and safer.Shift hours are 8 hour days, Monday-Friday.
A Day in the Life
Provide independent quality oversight of GMP manufacturing operations, including aseptic processing
Perform and lead batch record review to ensure accuracy and compliance with regulatory and internal requirements
Lead and support deviation investigations, root cause analysis, and CAPA development and effectiveness checks
Utilize electronic quality systems such asTrackWiseand Documentum to manage documentation and workflows
Partner with Manufacturing, Validation, Engineering, and Regulatory teams to support compliant operations
Support andparticipatein regulatory inspections, internal audits, and customer audits
Apply knowledge of aseptic manufacturing controls, cleanroom operations, and gowning practices
Mentor andprovidetechnical guidance to QA Technicians and peers
Identifyopportunities for continuous improvement and quality system enhancements
Ensure compliance with site procedures, safety requirements, and data integrity standards
Keys to Success
Education
High school diploma or equivalent required.
Bachelor’s degree preferred in Chemistry, Pharmacy, Biology, Biotechnology, or a related scientific discipline, preferred.
Equivalent experience in a GMP-regulated environment will be considered
Experience
A minimum of 3 years of experience in pharmaceutical quality assurance or a related GMP-regulated manufacturing environment
Demonstrated experience supporting aseptic manufacturing and sterile operations
Experience supporting regulatory inspections and customer audits
Demonstrated ability to work independently with limited supervision in a dynamic environment
Knowledge, Skills, and Abilities
Advanced knowledge of GMP regulations, FDA guidance, and pharmaceutical quality systems
Strongexpertisein batch record review, deviation management, CAPA, and root cause analysis
Proficiencywith electronic quality management systems and documentation platforms
Strong written and verbal communication skills with the ability to effectively collaborate across functions
Excellent attention to detail with strong analytical and problem-solving skills
Ability to manage multiple priorities and adapt to changing production demands
Proficiencywith Microsoft Office applications
Ability to work various shifts as required by manufacturing operations
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How many Engineering jobs are open in Greenville, NC right now?
There are currently 86 open engineering positions in Greenville, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Greenville, NC?
Companies currently hiring include Thermo Fisher Scientific, Avient Corporation, Newcomb and Company, Catalent, Hyster-Yale Materials Handling, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Greenville, NC?
Yes — 7 of the 86 open engineering positions offer remote or hybrid work (1 remote, 6 hybrid).
How do I apply for Engineering jobs in Greenville, NC?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.