QA Shop Floor Lead - Cell Therapy Ops

Bristol Myers Squibb; New Jersey; On-site; USD 70,000 - 100,000; Full time

Job summary

Bristol Myers Squibb seeks a Specialist, QA Operations to oversee quality activities across Cell Therapy Development Operations. The role ensures compliance with cGMP standards and supports batch release, documentation, and investigations.

Responsibilities include shop floor QA walkthroughs, label control, change control, and SOP reviews, with strong cross-functional collaboration across Manufacturing, Supply Chain, QA, and QC teams.

Qualifications

• 1-2 years of experience within QA functions in the pharmaceutical industry.
• Thorough knowledge of cGMP in the pharmaceutical industry.
• Knowledge and application experience with batch record review, product disposition/release, change control, SOP review, GMP inspection.
• Good computer skills and working knowledge of common business software.
• Excellent organizational skills.
• Excellent problem-solving, verbal, and written communication skills.
• Strong interpersonal and communication skills, be a team player.
• Must be an individual with proven initiative and demonstrated accountability.
• Professional integrity and maturity are required.

Responsibilities

• Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.
• Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.
• Revise department SOPs, as well as Review and QA Approval of CTDO SOPs
• Perform Real time review /approval of executed batch records and Chain of Identity verification.
• Responsible for ERP Material Status Changes of production/drug product
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
• Supports Risk Assessments/projects as required by senior management.

Job description

Bristol Myers Squibb seeks a Specialist, QA Operations to oversee quality activities across Cell Therapy Development Operations. The role ensures compliance with cGMP standards and supports batch release, documentation, and investigations.

Responsibilities include shop floor QA walkthroughs, label control, change control, and SOP reviews, with strong cross-functional collaboration across Manufacturing, Supply Chain, QA, and QC teams.