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QA Manufacturing Specialist

Edison-New Brunswick Metro Area, NJ

Post Date: 06/04/2018 Job ID: JN -062018-21751 Job Type: Scientific
  • B.S. in a scientific or engineering discipline
    2 or more years relevant experience, preferably in a GMP or regulated environment
    Experience writing deviations and investigations.

    Initiate deviations and perform routine investigations
    Participate in cross functional investigative teams deploying specific investigative principals
    as necessary to ensure root cause analysis and corrective action(s)
    Ensures corrective actions and improvements are shared and incorp
    orated into the
    appropriate processes
    Generate and execute CAPA documents to support response to deviations, audit findings and
    independent corrective actions

    Collaborate with QC team to prioritize and lead Continuous Improvement initiatives
  • The Specialist, Continuous Improvement, is responsible for supporting major deviations/investigations and CAPA s in regards to Manufacturing Operations at Cellular Therapeutics. In addition, they will also be responsible for assisting in developing and maintaining various programs and systems to ensure compliance and quality. This may include but not be limited to training, trending and continuous improvement endeavors.

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