Specialist - QA Shop Floor

Role: QA Specialist supporting routine cell therapy manufacturing operations at BMS Bothell, ensuring compliance with cGMP, GDocP, and Data Integrity principles. Responsibilities: real-time batch record review, manufacturing observations, review and approval of SOPs and work instructions, leading continuous improvement initiatives, and managing deviation triage including root cause analysis and timely closure of quality events. Requirements: Bachelor's in STEM or equivalent experience; 3-4 years of GxP experience in regulated environments like pharma, biotech, or cell therapy manufacturing; proficiency with manufacturing systems (MES, SAP, deviation management tools); strong attention to detail and risk-based decision-making skills. Preferred: experience with batch record review, deviation management, and product disposition. HighValue: cell therapy, cGMP, GDocP, Data Integrity, deviation management, manufacturing systems (MES, SAP), routine QA oversight. WorkSetup: shift Wednesday to Saturday, 13:30–00:00, Bothell, WA.