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    Sr. Quality Control Specialist - Philadelphia, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Philadelphia, United States

    3 weeks ago

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    Description

    606454

    Our client, a leading Pharmaceutical company in Philadelphia, PA, is looking for a Sr. Quality Control Specialist to be responsible for the review of the executed test methods and raw data for lot release

    Required Skills:

    • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
    • Minimum 5 years of experience in the biopharmaceutical industry within a Quality Control role
    • Must have experience with OOS investigations, deviations, change controls and CAPAs.
    • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
    • Solid understanding and functional knowledge with hands-on experience with Cell base Assays, cell culture (primary cells and cell lines),
    • Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)

    Responsibilities:

    • Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events.
    • Performs review and approval of CMO/CTL change controls.
    • Performs data analysis of CMO release testing to support product lot release with adherence to turnaround times.
    • Issue and write change controls and CAPAs when required.
    • Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations environment.
    • Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
    • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate documents.
    • Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.
    • All duties are performed with minimal supervision and oversight.
    • Performs other duties as assigned.

    ***Compensation within this range will be commensurate with level of experience***

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