Specialist QA Shop Floor Bothell, WA

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Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.
Position:

The QA Specialist within the Quality Assurance Shop Floor organization provides quality oversight for routine clinical and commercial cell therapy operations ensuring adherence to current Good Manufacturing Practices (cGMP).

This role serves as a subject matter expert (SME) in cGMP Good Documentation Practices (GDocP) and Data Integrity/ALCOA principles supporting quality risk management and right-first-time execution on the Shop Floor at BMS Bothell.

Responsibilities:

Perform real-time review of executed batch records to ensure compliance with procedures; collaborate with manufacturing teams to resolve discrepancies.

Observe manufacturing operations and identify departures from clean room behaviors aseptic techniques and cGMP practices through QA Walkthroughs Gemba and Process Observations.

Own review and approve moderate to complex operational documents such as Standard Operating Procedures (SOPs) and Work Instructions

Represent QA and execute tasks in continuous improvement initiatives including Kaizen events 5S activities and cross-functional gemba.

Lead deviation triage activities ensuring quality events are assessed through a process- and risk-based lens; drive timely and coordinate closure of NI/RCA events aligned with quality performance metrics.

Reporting Relationship: This position reports to QA Shop Floor Manager