Specialist, QA Shop Floor

Overview

Bristol Myers Squibb offers challenging, meaningful, life-changing work across all departments. This role supports quality oversight on the Shop Floor for routine clinical and commercial cell therapy operations, ensuring adherence to current Good Manufacturing Practices (cGMP).

Shift: Sun-Wed 06:00-16:30

• Perform real-time review of executed batch records to ensure compliance with procedures; collaborate with manufacturing teams to resolve discrepancies.
• Quality Operator/Verifier for on-the-floor operations such as packaging, material receipt and label issuance.
• 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 operational documents such as Standard Operating Procedures (SOPs) and Work Instructions in the Document Management System.
• Provide quality support for deviation triage activities to identify initial containment and documentation for adverse events. Approve deviation Assessments in a timely manner aligned with quality performance metrics.

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

• 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 is preferred.
• Proficient in Microsoft Office applications (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 sound, risk-based decisions, escalating critical issues appropriately.

Bothell, WA: $38.42 - $46.55 per hour. Additional incentive cash and stock opportunities may be available. Final compensation will be based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on job and location. For more on benefits, visit the careers site.

• Healthcare:
  Medical, pharmacy, dental, and vision coverage.
• Wellbeing:
  Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial: 401(k) plan, disability, life insurance, and other protections.
• Paid Time Off and holiday provisions vary by location and role.

Supporting People With Disabilities: BMS provides accommodations and adjustments in recruitment and employment. For accommodations, contact  See the Equal Employment Opportunity statement on the careers site. Data protection and privacy information are provided in the posting. If you believe information is missing or incorrect, contact  with the Job Title and Requisition number.

R1598447 :
Specialist, QA Shop Floor