Cell Therapy Shop Floor QA Associate II

Bristol Myers Squibb; Harvard (MA); On-site; USD 49,000 - 59,000; Full time

Job summary

Bristol Myers Squibb’s Quality Assurance Shop Floor team oversees 24x7 quality collaboration across Manufacturing, QC laboratories, and Supply Chain Operations at the Devens site. The role ensures compliance with cGMP and site procedures while partnering with operations teams to maintain product quality and patient safety.

The position supports cross-functional teams, participates in inspections, and contributes to continuous improvement initiatives in a fast-paced cell therapy manufacturing

Qualifications

• 0-2 years of relevant cGMP experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Bachelor's degree in STEM preferred; HS diploma or Associate accepted.
• Willingness to work in a manufacturing environment with PPE.

Responsibilities

• Provide on-the-floor quality oversight to Manufacturing/ QC/ Supply Chain Operations and respond to issues.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and ensure aseptic techniques and clean room compliance.
• Support maintenance operations and pre-approved return to service plans.
• Conduct area walkthroughs and drive remediation to ensure cGMP adherence.
• Review manufacturing/testing records for compliance and escalate discrepancies.

Skills

Procedures compliance

MS Office

Problem solving

Cross-functional communication

Fast-paced teamwork

Detail oriented

Issue escalation

Self-motivated

Education

Bachelor's degree in STEM

High school diploma or Associate

Job description

Bristol Myers Squibb’s Quality Assurance Shop Floor team oversees 24x7 quality collaboration across Manufacturing, QC laboratories, and Supply Chain Operations at the Devens site. The role ensures compliance with cGMP and site procedures while partnering with operations teams to maintain product quality and patient safety.

The position supports cross-functional teams, participates in inspections, and contributes to continuous improvement initiatives in a fast-paced cell therapy manufacturing