Senior Specialist, Quality Assurance Laboratory Operations

Position Summary Quality Assurance Shop Floor (24x7 coverage) supporting Manufacturing, Quality Control labs, and Warehouse/Packout operations. Monday–Friday day shift; oversees and partners with operational areas to ensure compliance with BMS policies/standards/procedures and Global cGMP. Key Responsibilities Provide QA oversight; identify deviations from approved procedures; independently respond/escalate critical issues. Perform/document operational verification; observe clean room behaviors/aseptic techniques. Lead area walkthroughs (Gemba), coordinate remediations, and drive implementation alignment. Own/review/approve GxP Floor records (e.g., procedures, CAPAs, change controls, impact assessments, documentation, deviations); support deviation/alarm and other Quality System/Batches as requested. Author/review/approve procedural documents; act as QA representative in governance forums and cross-functional meetings. Track process performance via data/analytics; establish KPIs/standard work databases; champion quality culture and learning. Serve as SME for risk assessments, change controls, and GxP electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.). Qualifications & Required/Preferred Skills Ability to interpret/apply SOPs, policies, and regulatory guidelines. Strong computer/digital skills (MS Office; Power Automate/Smartsheet/Tableau preferred). Data interpretation; critical thinking and clear written/verbal communication. Quality management systems experience (change control, deviations, investigations, CAPA, product complaints). 4+ years relevant cGMP experience (prefer 1+ year site/manufacturing). FDA/EMA biopharma/cell therapy experience preferred. STEM bachelor’s preferred (HS/AA may be considered). Benefits (if eligible) Health coverage (medical/pharmacy/dental/vision); wellbeing programs (EAP); 401(k); life/disability/insurance. Paid time off (e.g., flexible time off for US exempt employees or vacation + holidays for specific locations/categories). Application Instructions Apply for the role. #J-18808-Ljbffr Scorpion Therapeutics