Senior Specialist, QA Manufacturing Shop Floor, Cell Therapy

Responsibilities

• Provide direct Quality Assurance oversight to Manufacturing, QC, Warehouse, and Packout operations
• Identify departures from approved procedures and respond to complex issues independently
• Own quality decision-making regarding unexpected production floor events and deviation triage
• Review and quality approve GxP records, including procedures, batch records, and deviations
• Lead area walkthroughs and Gemba walks to identify quality issues and negotiate remediations
• Author, review, and approve procedural documents and non-routine event response procedures
• Serve as a Quality subject matter expert for risk assessments and change controls
• Maintain compliance with assigned learning plans and provide guidance to QA personnel
• Utilize electronic systems such as MES, SAP, and QMS to manage quality records

Requirements

• 4+ years of relevant cGMP experience, preferably with manufacturing site experience
• Direct QA experience providing support to GMP manufacturing operations
• Proven experience with quality management systems (change control, deviations, CAPA)
• Experience with GxP electronic systems (e.g., MES, SAP, LIMS, or QMS)
• Ability to research, interpret, and apply internal SOPs and regulatory guidelines
• Strong ability to interpret data and articulate practical solutions to complex problems
• Excellent written and verbal communication skills for technical data presentation
• Bachelor's degree in a STEM field preferred

About the Company

Bristol Myers Squibb is a global biopharmaceutical company that seeks to discover, develop, and deliver innovative medicines that help patients prevail against serious diseases. We offer a collaborative environment where uniquely interesting work happens every day, from optimizing production lines to achieving breakthroughs in cell therapy.