Associate II - QA Shop Floor

Position Summary

The QA Associate II is part of the QA Shop Floor organization, supporting routine clinical and commercial cell therapy operations at BMS Bothell. This role ensures ongoing compliance with cGMP requirements across Manufacturing, Quality Control, and Warehouse areas.

Key Responsibilities

• Review executed batch records to ensure compliance with approved procedures; communicate and resolve discrepancies with manufacturing operators or supervisors
• Provide Quality oversight on the shop floor through QA Walkthroughs, Gemba, and Process Observations to ensure full adherence to cGMP practices
• Participate in routine cell therapy manufacturing operations, including Product Packout, Apheresis Receipt, CMAT Receipt, and Finished Drug Product Label Review and Verification
• Identify and implement improvements to walkthrough and batch review processes, as well as broader process improvement initiatives

This role reports to the QA Shop Floor Manager.

Shift Schedule

Sunday – Tuesday + Alternating Wednesdays | 6:00 PM – 6:30 AM

Education

• Bachelor's degree in a STEM field preferred
• High School Diploma or Associate degree with an equivalent combination of education and work experience may be considered

Experience and Skills

• 1–2 years of relevant cGMP experience in a pharma, biotech, or cell therapy manufacturing regulated environment
• Hands-on experience with batch record review preferred
• Proficiency in electronic manufacturing systems such as MES, ERP, eQMS is preferred
• Detail-oriented with strong planning, organization, time management, and execution skills

Pay

$34.92 – $42.32 per hour (Bothell, WA). The starting pay rate takes into account required skills, job location, work schedule, job-related knowledge, and experience. Additional incentive cash and stock opportunities may be available based on eligibility.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Paid Time Off: US Exempt employees receive flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio). Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees receive 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

This response is AI-generated, for reference only.