QA Shop Floor Specialist - Real-Time Quality & Compliance

Biopharma Careers; Bothell (WA); On-site; USD 52,000 - 63,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Job summary

Bristol Myers Squibb is seeking a QA Shop Floor Specialist in Bothell, WA to provide quality oversight for routine cell therapy operations, ensuring cGMP adherence. The role demands SME knowledge of GxP, GDocP, and ALCOA+ with focus on risk-based decision making.

The position supports QA Walkthroughs, deviation triage, and continuous improvement in a highly regulated production environment. Competitive pay and comprehensive benefits are offered.

Qualifications

• 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 MES, ERP (SAP), Deviation Management (Infinity) and Document Management (BMSDocs).

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 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.

Skills

GxP experience

cGMP

GDocP

ALCOA+

QA Walkthroughs

Kaizen

5S

Gemba

Deviation management

Document management

Education

Bachelor's degree in STEM

Associates degree with equivalent education/experience

Tools

MES

SAP

Infinity

BMSDocs

Microsoft Office

Job description

Bristol Myers Squibb is seeking a QA Shop Floor Specialist in Bothell, WA to provide quality oversight for routine cell therapy operations, ensuring cGMP adherence. The role demands SME knowledge of GxP, GDocP, and ALCOA+ with focus on risk-based decision making.

The position supports QA Walkthroughs, deviation triage, and continuous improvement in a highly regulated production environment. Competitive pay and comprehensive benefits are offered.