VetJobs
Specialist - QA Shop Floor - Bothell, WA
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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). 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
Minimum Education Required: High School/GED Education: Bachelor\'s degree in STEM (Science, Technology, Engineering and Math) preferred; Associate degree with equivalent combination of education and work experience may be considered. Experience: 3–4 years of cGMP experience in a regulated environment such as pharmaceuticals, biotechnology, or cell therapy manufacturing; experience in batch record review, deviation management, and/or product disposition preferred. 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) Strong attention to detail with effective organizational, planning, and time management skills. Familiarity with quality risk management principles and ability to make sound, 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
Bothell, WA: $38.42 - $46.55 per hour Location
Bothell, Washington Company
VetJobs / Bristol Myers Squibb (BMS) – Note: The original ad references Bristol Myers Squibb; this description reflects the role and organization details as provided.
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Join to apply for the Specialist - QA Shop Floor - Bothell, WA role at VetJobs 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). 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
Minimum Education Required: High School/GED Education: Bachelor\'s degree in STEM (Science, Technology, Engineering and Math) preferred; Associate degree with equivalent combination of education and work experience may be considered. Experience: 3–4 years of cGMP experience in a regulated environment such as pharmaceuticals, biotechnology, or cell therapy manufacturing; experience in batch record review, deviation management, and/or product disposition preferred. 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) Strong attention to detail with effective organizational, planning, and time management skills. Familiarity with quality risk management principles and ability to make sound, 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
Bothell, WA: $38.42 - $46.55 per hour Location
Bothell, Washington Company
VetJobs / Bristol Myers Squibb (BMS) – Note: The original ad references Bristol Myers Squibb; this description reflects the role and organization details as provided.
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