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    Quality Control Analyst - Irvine, CA, United States - Abbvie

    Abbvie
    Abbvie Irvine, CA, United States

    1 week ago

    Default job background
    Full time
    Description

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

    We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

    For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
    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 testing.
    Perform environmental monitoring, bioburden, endotoxin and general microbiology tests
    Ensure that all test equipment is used and maintained correctly.
    Ensure all in-process sampling and testing is completed on time.
    Able to support manufacturing for testing during different shifts
    Assist in the resolution of quality problems as required.
    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
    Authoring and review of documents such as protocols, reports, test methods, SOPs.
    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.
    Bachelor's Degree in Sciences, with a minimum of three (3) years of lab experience in a QC GMP environment
    Experience in microbiology tests such as bioburden, sterility, environmental monitoring, endotoxin

    Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.

    Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

    We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

    This job is eligible to participate in our short-term incentive programs. ​

    AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

    It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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