Specialist - QA Shop Floor
Bristol Myers Squibb
September 02, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Summary
The QA Specialist (Quality Assurance Shop Floor) provides quality oversight for routine clinical and commercial cell therapy operations, ensuring adherence to current cGMP.
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 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, assessing quality events through a process- and risk-based lens; drive timely and coordinate closure of NI/RCA events aligned with quality performance metrics.
Shift Schedule
Wednesday to Saturday, 13:30–00:00.
Reporting Relationship
Reports to QA Shop Floor Manager.
Qualifications
- Bachelor’s degree in a STEM field preferred; Associate degree with equivalent education and work experience may be considered.
- 3–4 years of GxP experience in a regulated environment (pharma/biotech/cell therapy manufacturing) or equivalent.
- Preferred: experience in batch record review, deviation management, and/or product disposition.
- Proficient in Microsoft Office (Word, Excel); manufacturing systems proficiency (MES, ERP/SAP, Deviation Management/Infinity, Document Management/BMSDocs).
- Strong attention to detail; organizational/planning/time management skills.
- Familiarity with quality risk management; ability to make risk-based decisions and escalate critical issues.
Benefits / Compensation
Bothell, WA, US: $38.42–$46.55 per hour. (Starting range for full-time employees; may be eligible for additional discretionary incentive cash and stock.)
Benefits may include wellbeing support, retirement/financial protection, and insurance (medical, dental, vision, life, disability), plus Flexible Time Off and paid holidays depending on eligibility.
Application Instructions
U.S.-based job seekers can explore benefits at https://careers.bms.com/benefits.
The QA Specialist (Quality Assurance Shop Floor) provides quality oversight for routine clinical and commercial cell therapy operations, ensuring adherence to current cGMP.
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 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, assessing quality events through a process- and risk-based lens; drive timely and coordinate closure of NI/RCA events aligned with quality performance metrics.
Shift Schedule
Wednesday to Saturday, 13:30–00:00.
Reporting Relationship
Reports to QA Shop Floor Manager.
Qualifications
- Bachelor’s degree in a STEM field preferred; Associate degree with equivalent education and work experience may be considered.
- 3–4 years of GxP experience in a regulated environment (pharma/biotech/cell therapy manufacturing) or equivalent.
- Preferred: experience in batch record review, deviation management, and/or product disposition.
- Proficient in Microsoft Office (Word, Excel); manufacturing systems proficiency (MES, ERP/SAP, Deviation Management/Infinity, Document Management/BMSDocs).
- Strong attention to detail; organizational/planning/time management skills.
- Familiarity with quality risk management; ability to make risk-based decisions and escalate critical issues.
Benefits / Compensation
Bothell, WA, US: $38.42–$46.55 per hour. (Starting range for full-time employees; may be eligible for additional discretionary incentive cash and stock.)
Benefits may include wellbeing support, retirement/financial protection, and insurance (medical, dental, vision, life, disability), plus Flexible Time Off and paid holidays depending on eligibility.
Application Instructions
U.S.-based job seekers can explore benefits at https://careers.bms.com/benefits.