Cell Therapy Shop Floor QA: Associate II

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

Benefits offered by this job

Wellbeing support

Retirement benefits

Insurance (medical, dental, vision, L)

Job summary

Bristol Myers Squibb is seeking a Shop Floor QA Associate in Devens, MA. You will oversee manufacturing, QC and supply chain activities, ensuring adherence to cGMP and approved procedures. The role requires strong documentation and problem-solving across teams.

The position emphasizes hands-on quality oversight, area walkthroughs, and support for continuous improvement, with a 6am–6pm rotating shift and full benefits.

Qualifications

• Bachelor's degree in STEM field; 0-2 years of cGMP experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Ability to communicate effectively with cross functional peers and management.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures.
• Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and upscale as required.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Maintain compliance with assigned learning plan.
• Support internal and external inspections as required.
• Contribute to the assessment of discrepancies and initiation of quality events.
• Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
• Build relationships within direct team and partner functions.

Skills

Procedures

MS Office

Cross-functional comms

Problem solving

Attention to detail

Education

Bachelor's degree in STEM field

Job description

Bristol Myers Squibb is seeking a Shop Floor QA Associate in Devens, MA. You will oversee manufacturing, QC and supply chain activities, ensuring adherence to cGMP and approved procedures. The role requires strong documentation and problem-solving across teams.

The position emphasizes hands-on quality oversight, area walkthroughs, and support for continuous improvement, with a 6am–6pm rotating shift and full benefits.