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Posiion - QA Lab Person in Plant

Locataion - Newark, NJ

Duration - 9 months

Job Description:
Client is looking for a QA Associate for Lab/manufacturing oversight to support a Cell Therapy tech transfer to their CDMO. 10+ years working in a QA capacity for an aseptic manufacturing and lab facility. Must be familiar with all tech transfer activities. Should have a microbiology background and Must be strong in reviewing test methods and ensuring the product testing is in compliance.
Day-to-Day tasks
Provide Quality support for site and process qualification activities, engineering runs, and commercial product manufacturing.
Remote quality support for production activities, including deviation and CAPA review, escalation of critical issues, batch review and release and change control.
Support monitoring of EM quality performance and proactively identify risks.
Influence and build relationship with internal and external partners to continuously enhance quality performance.
Interface with other functions (Operations, Planning, Technical Operations, etc.) within Client as well as the external manufacturer
Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
Provide on-site support as needed on request of the Client team lead