Senior Specialist, QA Shop Floor

Role: Senior Specialist in QA Shop Floor overseeing 24/7 quality operations within manufacturing, QC, Label Ops, and Warehouse at Bristol Myers Squibb. Responsibilities: ensure compliance with cGMP policies, conduct on-the-floor oversight, review manufacturing/testing records, approve deviations, author and review SOPs, lead area walkthroughs, and act as Authorized Person for drug release per GMP requirements. Also, provide training, support risk assessments, and lead cross-functional meetings. Requirements: Bachelor's in STEM (or equivalent experience), 4+ years of relevant cGMP experience, preferably in biopharmaceutical manufacturing (cell therapy, biologics), with knowledge of FDA/EMA regulations, manufacturing systems (MES, ERP), and quality management. Skills include interpreting policies, data analysis, effective communication, leadership, and problem-solving. Preferred: experience in manufacturing site operations, quality systems, and regulatory compliance. HighValue: cGMP manufacturing, biopharma (biologics/cell therapy), regulatory compliance, shift-based work (varied hours), involvement in quality oversight and release activities, familiarity with electronic systems. WorkSetup: multiple shifts, on-site at NJ facility.