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    Quality Control Manager - London, United Kingdom - Vertex

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    Full time
    Description

    Job Description

    General Summary:

    The Quality Control Manager provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner.

    Key Duties and Responsibilities:

    • Serves as QC representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs
    • Manages various laboratory program(s)/processes within the department and serves as subject matter expert (SME)
    • Coordinates and facilities laboratory activities to meet commitments on-time
    • Leads planning, coordination and/or review of method validations, method transfers and/or equipment qualification/requalification
    • Assist in troubleshooting of analytical methods and/or equipment as required
    • Authors, reviews, and/or approve data, SOPs, COAs, analytical methods, protocols and reports
    • Monitors, tracks, and publishes lab metrics
    • Ensures all laboratory records adhere to cGMP/GDP expectations
    • Leads compliance related teams working towards the goal of continuous improvement
    • May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence

    Knowledge and Skills:

    • Strong knowledge of UK and EU cGMP regulations/guidance and some experience with regulatory agency inspections
    • Strong knowledge of analytical methodologies such as chromatography, flow cytometry, viable cell counting, cell-based potency assays, endotoxin, sterility, mycoplasma and qPCRs assays.
    • Effective communication skills, both verbal and written
    • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

    Education and Experience:

    • Bachelor's Degree in science or related discipline is required.
    • Extensive experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience


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