Senior Specialist, QA Shop Floor M-F, Cell Therapy

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.

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.

This position works a Monday to Friday schedule, Day shift. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

In the capacity of Shop Floor QA, the Senior Specialist shall serve as one of the Shop Floor Representatives interacting with Manufacturing, Supply Chaing, Quality Control and other supporting teams.

The Senior Specialist, Shop Floor QA, is accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represents SFQA at relevant governance forums.

Additionally, the incumbent shall to support deviation approval, alarm approval, other Quality System Records, or batch record review as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Senior Manager, Quality Assurance Shop Floor Monday to Friday Team. This is an individual contributor role working Monday to Friday.

• Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & respond to complex issues independently & elevate critical issues to management.
• May perform and document operational verification per approved procedures.
• Develops, reviews and/ or approves temporary and non routine procedure 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 to programs.
• Participate in Gemba walks.
• Communicate and resolve discrepancies independently and elevate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
• May own training curriculum and content.
• May present individual topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent function at cross functional meetings.
• Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.
• Periodically observe operations occurring on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in…