Senior Specialist, Field Quality QA Operations

Senior Field QA Specialist responsible for quality oversight on the manufacturing floor, including real-time MBR reviews, on-the-floor exception logging, GMP area walkthroughs, RTS readiness, deviation investigation/resolution, and contributing to SOP authoring/revisions. Collaborates with Manufacturing Operations to ensure product release readiness, proper cleaning/calibration of equipment, and audit preparedness. Performs training on routine quality tasks, ensures documentation compliance (electronic and paper), and supports area inspections and readiness reviews to uphold cGMP regulations and internal standards. Requires knowledge of biotech bulk/finished product manufacturing, US/EU cGMP guidance, batch record systems, and related electronic systems (e.g., DeltaV). Shift: Monday–Friday, 2:00 PM–10:30 PM; onsite at Devens, MA.