Bristol Myers Squibb
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Specialist - QA Shop Floor
role at
Bristol Myers Squibb Location:
Bothell, WA, US (onsite) Overview
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
Bachelor's degree in STEM (Science, Technology, Engineering and Math) preferred; an Associates degree with equivalent education and experience may be considered. 3-4 years of cGMP experience in a regulated environment (pharmaceuticals, biotechnology, or cell therapy manufacturing). Experience in batch record review, deviation management, and/or product disposition is preferred. Proficient in Microsoft Office (Word, Excel) and manufacturing systems such as MES, ERP (SAP), Deviation Management (Infinity) and Document Management (BMSDocs). Strong attention to detail with effective organizational, planning, and time management skills. Familiarity with quality risk management principles and ability to make risk-based decisions, escalating critical issues appropriately. Schedule
Sun-Wed | 10:30 am - 9:00 pm OR Wed-Sat 10:30 am - 9:00 pm Compensation and Benefits
Bothell, WA: $38.42 - $46.55 per hour. The starting compensation range for a full-time employee (FTE) basis, with additional incentive cash and stock opportunities (based on eligibility). Eligibility for specific benefits varies by job and location. Benefits may include medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid time off, holidays, and other programs. Details at the careers site. On-site and Accessibility
BMS has an occupancy structure to determine where work is performed (site-essential, site-by-design, field-based, remote-by-design). Reasonable workplace accommodations are available; inquiries may be directed to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the Equal Employment Opportunity statement. Providing equal opportunity in employment and encouraging vaccination as part of company policy. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Bristol Myers Squibb. Get notified about new Quality Assurance Specialist jobs in Bothell, WA.
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Specialist - QA Shop Floor
role at
Bristol Myers Squibb Location:
Bothell, WA, US (onsite) Overview
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
Bachelor's degree in STEM (Science, Technology, Engineering and Math) preferred; an Associates degree with equivalent education and experience may be considered. 3-4 years of cGMP experience in a regulated environment (pharmaceuticals, biotechnology, or cell therapy manufacturing). Experience in batch record review, deviation management, and/or product disposition is preferred. Proficient in Microsoft Office (Word, Excel) and manufacturing systems such as MES, ERP (SAP), Deviation Management (Infinity) and Document Management (BMSDocs). Strong attention to detail with effective organizational, planning, and time management skills. Familiarity with quality risk management principles and ability to make risk-based decisions, escalating critical issues appropriately. Schedule
Sun-Wed | 10:30 am - 9:00 pm OR Wed-Sat 10:30 am - 9:00 pm Compensation and Benefits
Bothell, WA: $38.42 - $46.55 per hour. The starting compensation range for a full-time employee (FTE) basis, with additional incentive cash and stock opportunities (based on eligibility). Eligibility for specific benefits varies by job and location. Benefits may include medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid time off, holidays, and other programs. Details at the careers site. On-site and Accessibility
BMS has an occupancy structure to determine where work is performed (site-essential, site-by-design, field-based, remote-by-design). Reasonable workplace accommodations are available; inquiries may be directed to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the Equal Employment Opportunity statement. Providing equal opportunity in employment and encouraging vaccination as part of company policy. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Bristol Myers Squibb. Get notified about new Quality Assurance Specialist jobs in Bothell, WA.
#J-18808-Ljbffr