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    Quality Control Analyst - Irvine, United States - AbbVie

    AbbVie
    AbbVie Irvine, United States

    3 weeks ago

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    Description
    Job Description


    While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

    Job Description

    Understand Regulations and business processes required to maintain Laboratory Data Integrity.

    Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements

    Responsible for the timely completion of chemical/laboratory testing.

    Knowledge in general chemistry testing (GC, HPLC, TOC, pH, UV concentration)

    Able to support manufacturing for testing during different shifts

    Ensure that all test equipment is used and maintained correctly.

    Ensure all in-process sampling and testing is completed on time.

    Maintain up-to-date, complete and precise records of all tests performed.

    Adhere to cGMP requirements.

    Assist in the resolution of quality problems as required.

    Develop/update in-house laboratory procedures as appropriate.

    Support the transfer of new products.

    Adhere to and supports all EHS & E standards, procedures and policies

    Support the qualification of new laboratory equipment

    Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out – of -specification (OOS) results

    Participate in analytical method transfers and validations

    Authoring and review of documents such as protocols, reports, test methods, SOPs.

    Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.
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