QC Microbiology Associate - Cambridge, United States - The Accuro Group

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    Description

    Business Title:
    | QC Microbiology Associate

    Location:
    Cambridge, MA 02142


    Job Type:
    Contract (12 Months)

    Note:
    Parking will not be reimbursed by the CLIENT. Parking is roughly $420/mo.


    Job Responsibilities:
    Perform routine environmental monitoring of the manufacturing facility.
    Perform routine sampling and testing of the utility systems.
    Perform Manufacturing Process Monitoring Perform QC sample receipt and aliquoting, as necessary.
    Complete documentation in accordance with current Good Manufacturing Practices (cGMP) ensuring data integrity.
    Support Laboratory investigation, deviation management and CAPA.
    Maintain QC Micro related systems to ensure compliance with industry standards supporting internal/external audits.
    Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies.
    Assist in the generation, review and approval of protocols, reports, and CofA.
    Perform environmental monitoring and utility samples of the facility.


    Skills & Experience Required:
    Bachelor's degree in relevant field.
    3+ years of experience.
    Knowledge of GMP, microbiology, aseptic technique, and general laboratory instrumentation.
    Experience performing lab investigation, deviation writing, participate in change controls, and CAPAs investigations.
    Bioburden and endotoxin testing experience.
    A background authoring and revising standard operating procedures.