Specialist - QA Shop Floor

Role Summary

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.

Qualifications

• Required: 3-4 years of cGMP experience in a regulated environment such as pharmaceuticals, biotechnology, or cell therapy manufacturing.
• Preferred: Experience in batch record review, deviation management, and/or product disposition.
• Required: Proficient in Microsoft Office applications (Word, Excel) and demonstrated proficiency in manufacturing systems such as MES, ERP (SAP), Deviation Management (Infinity) and Document Management (BMSDocs).
• Required: Strong attention to detail with effective organizational, planning, and time management skills.
• Required: Familiarity with quality risk management principles and ability to make sound, risk-based decisions, escalating critical issues appropriately.

Education

• Bachelor's degree in STEM (Science, Technology, Engineering and Math) field preferred.
• Associates degree with equivalent combination of education and work experience may be considered.