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Specialist - QA Shop Floor
$79,914–$96,824 year
On-site · Bothell, Washington, United States
Job Summary
QA Specialist on the Shop Floor oversees routine clinical and commercial cell-therapy operations for cGMP compliance. Acts as SME in cGMP, GDocP, and ALCOA+ data integrity, supporting quality risk management and right-first-time execution on the Shop Floor at BMS Bothell. Responsibilities include real-time review of executed batch records, collaboration with manufacturing to resolve discrepancies, QA walk-throughs to ensure aseptic technique and adherence to procedures, and leading deviation triage with risk-based assessment and closure of NI/RCA events. Also responsible for reviewing SOPs and Work Instructions, participating in continuous improvement initiatives (Kaizen, 5S, Gemba), and maintaining familiarity with manufacturing systems (MES, SAP, Infinity) and documentation tools (BMSDocs). Schedule is Wednesday–Saturday, 13:30–00:00. Compensation ranges from $38.42–$46.55 per hour for full-time employment, with potential incentive cash and stock opportunities; benefits vary by location. Bothell, WA, US site-specific details about onsite/occupational models describe site-essential and hybrid/work-design options. The role emphasizes collaboration with cross-functional teams to ensure quality compliance and data integrity across manufacturing operations.
Required Qualifications
- Bachelor's degree in STEM (Science, Technology, Engineering and Math) preferred; Associates may be considered
- 3–4 years of GxP or equivalent experience in a regulated environment such as pharmaceuticals, medical devices, biotechnology, or cell therapy manufacturing
- Proficiency with Microsoft Office; familiarity with MES, SAP, Infinity, and Document Management (BMSDocs) systems
- Experience with batch record review, deviation management, and product disposition; strong attention to detail and organizational skills
- Knowledge of cGMP, GDocP, and ALCOA+ principles; ability to lead deviation triage and coordinate RCA/NI events
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