
Description
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.
- Bachelor's 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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