QA Specialist, Quality Operations

OBJECTIVES: The Quality Operations Specialist is responsible for day-to-day quality operations activities by supporting manufacturing being on the floor during both Drug Substance (DS) and Drug Product (DP) manufacturing at a scale appropriate for clinical trial stage R&D/CMC development operations and GMP manufacturing operations. The incumbent provides quality oversight on manufacturing batch record review and approval, manufacturing lot disposition, review and approval of site-specific proce…