Specialist - QA Shop Floor

Bristol Myers Squibb; Bothell (WA); On-site; USD 52,000 - 63,000; Full time

Job summary

Bristol Myers Squibb is hiring a QA Specialist for the Shop Floor in Bothell, WA. The role focuses on quality oversight of cGMP cell therapy operations, serving as SME in GDocP and ALCOA+ principles.

Collaboration with manufacturing teams ensures right-first-time execution on the shop floor. The position requires 3–4 years of GxP experience, proficiency with SOPs, batch records, and deviation management, and strong attention to detail.

Qualifications

• Requires 3–4 years of GxP experience in a regulated environment (pharma/biotech/cell therapy).
• Experience with batch record review and deviation management preferred.
• Proficiency in MS Word/Excel; experience with MES, SAP, Infinity, and BMSDocs.
• Strong attention to detail; good organizational and time-management skills.

Responsibilities

• Perform real-time batch record reviews to ensure adherence to procedures.
• Observe operations and identify deviations from cGMP, aseptic techniques and clean room practices.
• Review and approve SOPs and work instructions.
• Lead deviation triage and drive closure of NI/RCA events.
• Support continuous improvement initiatives such as Kaizen, 5S and gemba walks.

Skills

GxP experience

Batch record review

Quality risk management

Attention to detail

SOPs and Work Instructions

Education

Bachelor's degree in STEM

Associates degree with equivalent experience

Tools

MES

SAP ERP

Infinity Deviation Management

BMSDocs Document Management

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 Schedule:

The routine schedule for this position is Wednesday to Saturday, 13:30 - 00:00 Hours.

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.

Reporting Relationship:

This position reports to QA Shop Floor Manager

Qualifications:

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 GxP experience in a regulated environment such as pharmaceuticals, biotechnology, or cell therapy manufacturing, or equivalent experiences.
• 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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

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

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. (https://careers.bms.com/life-at-bms/ways-of-working/)

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605597 : Specialist - QA Shop Floor

Req Number: R1605597

Location: Bothell - Washington - US

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.