Lead QA Technician - Batch Record Review (8hr days, Monday-Friday)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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—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 trial logistics , 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 enabling Thermo Fisher 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 as TrackWise and Documentum to manage documentation and workflows Partner with Manufacturing, Validation, Engineering, and Regulatory teams to support compliant operations Support and participate in regulatory inspections, internal audits, and customer audits Apply knowledge of aseptic manufacturing controls, cleanroom operations, and gowning practices Mentor and provide technical guidance to QA Technicians and peers Identify opportunities 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 Strong expertise in batch record review, deviation management, CAPA, and root cause analysis Proficiency with 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 Proficiency with Microsoft Office applications Ability to work various shifts as required by manufacturing operations Competencies Demonstrates Thermo Fisher Scientific leadership attributes Acts as a role model for quality and compliance Customer-focused with a continuous improvement mindset Accountable, self-directed, and results-oriented Effective collaborator and communicator Committed to mentoring and developing others