NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA

Working with Us

Challenging. Meaningful. Life‑changing. Those aren’t words usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms patients’ lives and the careers of those who do it. You’ll grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more

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.

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 Warehouse Operations. The Senior Specialist, Quality Assurance Shop Floor, Cell Therapy position will oversee and partner with operational areas to ensure GxP compliance with Bristol‑Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions.

The Senior Specialist is accountable to own quality decision making as it relates to unexpected events on the production floor, deviation triage and determination, participation in cross‑functional triage meetings, review or quality approval of GxP records, support of deviation approval, alarm approval, and other Quality System Records as requested by management.

B2 – 6 pm – 6 am, rotating schedule including holidays and weekends, onsite.

• Provide quality oversight to Manufacturing, QC, Warehouse and Packout operations; identify departures from approved procedures and respond to complex issues independently, escalating critical issues to management.
• May perform and document operational verification per approved procedures.
• Develop, review and/or approve temporary and non‑routine procedures for event response.
• Observe manufacturing operations and identify departures from clean‑room behaviors and aseptic techniques.
• Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements.
• Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with the assigned learning plan; provide guidance and training for QA personnel.
• May own training curriculum and content.
• Independently assess discrepancies for entry into the quality system and approve records as applicable.
• Lead meetings and represent the function at cross‑functional meetings.
• Share data and knowledge within and across the team; build and maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.
• Observe operations occurring on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Able to influence others based on time and task commitments, organize/run meetings.
• Obtain access to and develop as an SME for various electronic systems utilized by QA Shop Floor, such as BMSDocs, CELabs, MES, SAP, ValG, Delta
  
  V, Maximo, Infinity, etc.
• Familiar with GMP‑related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.

• Ability to…