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

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