Specialist, QA Shop Floor

Overview

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:

Position Summary:

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.

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 Document Management System.

• Quality support for deviation triage activities to identify initial containment and documentation for adverse events. Approval of deviation Assessments in timely manner aligned with quality performance metrics.

Education:

• Bachelor's degree in STEM (Science, Technology, Engineering and Math education) field preferred.

• Associates 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 is 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Bothell - WA - US: $38.42 - $46.55 per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

• Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection.

• Work-life benefits: Paid Time Off and related programs.

Based on eligibility, additional time off may…