Quality Control Associate CAR-T Manufacturing

Quality Control Associate CAR-T Manufacturing
Parsippany NJ

• Conducted QC testing for CAR-T cell therapy products in a GMP-compliant commercial manufacturing environment, ensuring timely release of critical therapies.
• Performed flow cytometry and cell count analysis , demonstrating proficiency in operating flow cytometers and interpreting complex cell data.
• Utilized eLIMS and TrackWise quality systems to document results, manage laboratory workflows, and support traceability and compliance.
• Authored detailed laboratory issue reports and non-conformance reports , contributing to continuous improvement and root cause investigations during Quality Issues (QI) .
• Applied extensive knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to uphold data integrity and regulatory compliance.
• Played a key role in FDA audit preparation , helping ensure laboratory readiness through documentation review, procedural alignment, and staff training support.
• Trained in cryogenic sample handling , including LN2 procedures and CryoPod operations , maintaining sample integrity throughout storage and transfer processes.

Education and Required Skills

• Bachelors degree in Biological Sciences, Biotechnology, or a related field
• Hands-on experience working in a GMP-regulated laboratory environment
• Proficiency in flow cytometry techniques and cell culture practices, including aseptic technique and cell-based assays

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