Specialist - QA Shop Floor

Bristol Myers Squibb; United States; On-site; USD 52,000 - 63,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Wellbeing support

Job summary

Bristol Myers Squibb is seeking a QA Specialist to provide quality oversight for routine cell therapy operations on the Shop Floor in Bothell, WA. You will act as a SME in cGMP, GDocP, and Data Integrity, ensuring right-first-time execution and quality risk management.

The role requires real-time batch review, SOP/document management, and participation in continuous improvement initiatives. The position operates on a Wednesday-Saturday night shift, reporting to the QA Shop Floor Manager.

Qualifications

• Bachelor's degree in STEM preferred.
• Associates degree with relevant experience may be considered.
• 3-4 years of GxP experience in a regulated environment.
• Experience with batch records review, deviation management, or product disposition is preferred.
• Proficiency with Microsoft Office and manufacturing systems like MES, SAP, and document management.

Responsibilities

• Perform real-time review of batch records to ensure compliance and coordinate with manufacturing to resolve discrepancies.
• Observe operations and ensure aseptic technique and cGMP practices.
• Review and approve SOPs and work instructions.
• Lead continuous improvement activities (Kaizen, 5S) and cross-functional gemba.
• Lead deviation triage and coordinate NI/RCA closures with quality metrics.

Skills

GxP experience

MS Office

Batch record review

Deviation management

QA walkthroughs

Education

Bachelor's degree in STEM

Associates degree acceptable

Tools

MES

SAP

Infinity

BMSDocs

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 evaluation 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.

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