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    Quality Assurance Associate II - Malvern, United States - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson Malvern, United States

    3 weeks ago

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    OTHER
    Description
    Janssen Biotech, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II This position will be located in Malvern, PA.

    At Johnson & Johnson, we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity Learn more at

    On this team, we provide end to end quality oversight of GMP Quality Control Laboratories responsible for analytical testing of commercial and clinical products. You will act as a liaison with other internal quality organizations to standardize policies, practices, and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

    Main responsibilities will include, but are not limited to:
    • Partner with QC Laboratory Teams to provide QA oversight support of analytical method transfers, raw material testing and release, commercial and clinical product release, and stability testing activities.
    • Perform regularly scheduled oversight of the QC Laboratories.
    • Author and revise quality departmental documents as needed.
    • Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
    • Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
    • Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
    • Support process improvement activities including assessing current processes, providing improvement input, and working with partners to implement changes.
    • Support site inspections and inspection readiness activities. Ensure the QC Laboratories are audit ready. Support data integrity efforts.
    • Other duties may be assigned as necessary.
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