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    Quality Assurance Specialist - Novato, United States - Tucker Parker Smith Group (TPS Group)

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    Pharmaceutical / Bio-tech
    Description

    QA Document Control Specialist (Part Time)

    Location: Novato, CA (Hybrid)

    Pay Rate: $34/hr.

    7 month assignment (Strong potential to extend or convert to FTE)

    Our client, a global leader in biotechnology and innovation of therapies for rare and genetic diseases and life-threatening conditions is seeking a QA Documentation Control Specialist II that will be responsible for responsible for the maintenance of the cGMP controlled documentation system.

    Job Duties:

    • Process requests for document changes utilizing the EDMS.
    • Process document Special Handling requests.
    • Provide department metrics to management.
    • Participate in documentation audits.
    • Process logbook requests and perform routine audits.
    • Process laboratory notebook requests.
    • Responsible for maintaining Archive Room: filing, assisting customers.
    • Identifies improvements with group-level impact.

    Education & Experience:

    • Bachelor of Science degree in Biology, Biochemistry, Chemistry, Biotechnology, Molecular Biology, and QA experience is desired. 2-4 years of experience is preferred.
    • Preferred experience in auditing documentation
    • Proficiency in MS Word & MS Excel. Livelink and MS Access a plus
    • Experience in participation in regulatory inspections a plus
    • Understanding and familiarity with FDA and European regulatory requirements, guidelines

    Please submit your resume in a Word or PDF format to be considered



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