Associate II, Shop Floor Quality Assurance Cell Therapy

Bristol Myers Squibb; Harvard (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb is seeking a Quality Assurance professional to oversee shop-floor operations, ensuring adherence to cGMP and company standards. The role collaborates with Manufacturing, QC, and Supply Chain to maintain quality and compliance.

Shift available from 6am to 6pm on a rotating schedule, including holidays and weekends, with a focus on continuous improvement and effective issue resolution across functions.

Qualifications

• Experience applying approved procedures in a manufacturing setting.
• Ability to document and communicate quality events clearly.
• Familiarity with FDA/EMA quality standards and regulatory expectations.

Responsibilities

• Provide on-the-floor QA oversight to Manufacturing, QC, and Supply Chain Operations.
• Perform and document operational verification per approved procedures.
• Identify deviations from clean room behaviors and aseptic techniques, escalating as needed.
• Provide quality oversight to maintenance operations and support return-to-service plans.
• Review manufacturing or testing records for compliance and resolve discrepancies.
• Participate in cross-department and cross-functional meetings, sharing data and knowledge.

Skills

Quality Assurance

cGMP

Aseptic techniques

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

Summary

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain Operations.

This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

Shift Available

6am – 6pm, rotating (panama) schedule including holidays and weekends

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 elevate 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.

Knowledge & Skill

• Ability to understand, follow, and apply approved procedures
• Possess