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    pharmaceutical quality systems specialist - Rocklin, United States - Randstad

    Randstad
    Randstad Rocklin, United States

    2 weeks ago

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    Description

    Job Description

    Job Description

    IMMEDIATELY HIRING – PHARMACEUTICAL QUALITY SYSTEMS SPECIALIST

    Are you ready to be part of one of the largest pharmaceutical companies in the world, renowned for its commitment to excellence, innovation, and employee growth? Look no further, take the first step towards a fulfilling career today.

    As a Pharmaceutical Quality Systems Specialist, you will have the incredible opportunity to represent Quality on cross-functional teams to support business needs driving a positive site quality culture.

    APPLY NOW, join us and start playing a vital role in ensuring the quality and efficiency of our cutting-edge products.

    Location:

    Rocklin, CA

    Shift available:

    Mo – Fri, 7am-4:30pm

    Pay Rate:

    $26 -$27/hour

    What you will be doing:

    The Pharmaceutical Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system, and will represent Quality on cross-functional teams to support business needs driving a positive site quality culture.

    · Ensuring compliance of the quality system with regulations relevant to the business, including but not limited to ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.

    · Preparing Quality System documents and reports for site metrics and management review.

    · Writing, revising and/or reviewing Standard Operating Procedures.

    · Supporting internal and external audits as required.

    · Performing project review and audit of Device History Files (DHF's) and technical files.


    o Stability protocols and reports
    o Summary of Safety and Performance reports
    o Risk Management plans, reports, FMEAs
    o Post-Market Surveillance plans and reports
    o Performance evaluation plans and reports including scientific, clinical, and analytical documents.
    o Product composition reports
    o Sensitivity and specificity/Repeatability and reproducibility reports
    o Specification reports
    o General Safety and Performance Requirement reports

    This position is multi-disciplinary with opportunities to work on future products and current product and process improvements.

    The right candidate will have:

    · Bachelor's degree in any life science is preferred

    · At least 1 year of cGMP or Pharma industry experience

    · Experience reviewing docs in a GMP setting or worked in a quality role in a GMP setting.

    · Technical documentation for product design - PLUS

    TO APPLY: Email Resume to:

    If this job is not for you, feel free to refer a friend

    Company DescriptionRandstad Staffing. We provide outsourcing, staffing, consulting, and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration, and sales and marketing.

    We can't wait to tell you all about it

    Company Description

    Randstad Staffing. We provide outsourcing, staffing, consulting, and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration, and sales and marketing. \r
    \r
    We can't wait to tell you all about it
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