QA Shop Floor Specialist: Real-Time Quality Lead

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

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.