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    Senior Analyst, QC Operations - Boston, United States - bluebird bio

    bluebird bio
    bluebird bio Boston, United States

    Found in: Lensa US 4 C2 - 3 days ago

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    Description

    HOW YOU'LL FLY
    This is a hands-on role within Quality Control (QC) Operations, reporting to the Director of QC Operations. In this role, you will provide a significant contribution to the daily operations within Quality Control. You will partner with various internal laboratory operations as well as our Contract Testing Organizations (CTO) network.

    A normal day will include supporting all activities associated with testing at CTOs from sample submission to Certificate of Analysis (COA) approval.

    Additionally, you will provide valuable support in investigating any anomalous or out-of-specification results and/or driving QC document improvements through bluebird bio's quality system.

    You'll help to bring more patients their bluebird days by:

    Compiling, reviewing, and archiving CTO data and test records in support of COA generation

    Inputting lot and test data into QC trackers

    Scheduling sample shipments

    Owning and/or supporting testing related deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results

    Supporting document revisions related to method lifecycle and analytical method implementation

    Tracking & trending QC metrics


    WHAT YOU'LL BRING
    You're the bird we're looking for if you have:

    BS in a scientific discipline and 3+ years of related experience in QC GMP environment in a clinical and/or commercial environment

    Highly collaborative team player with experience being part of a team and working cross functionally

    Excellent organizational skills with an ability to navigate software and tools such as Veeva and Excel spreadsheets

    Experience with CTO/CMO interaction preferred

    Contract Length: 12 months


    Location:
    Remote (East coast based) or MA hybrid.

    #J-18808-Ljbffr
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