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    Documentation Specialist - Irvine, United States - Tucker Parker Smith Group (TPS Group)

    Tucker Parker Smith Group (TPS Group)
    Tucker Parker Smith Group (TPS Group) Irvine, United States

    1 week ago

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    Description

    Documentation Specialist

    Location: Irvine, CA

    Hours: 7:00 AM - 3:30 PM, Onsite

    Pay Rate: $27/hr.

    9 month contract (Great potential to extend or convert)

    On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level Documentation Specialist to join their team in Irvine, CA. As a Documentation Specialist, you will play a vital role in ensuring the smooth operation of our manufacturing processes by meticulously creating, processing, and reviewing production batch records in accordance with established GDP/GMP procedures.

    Duties:

    • Review documents for format, accuracy, and compliance with established procedures, collaborating with subject matter experts to provide feedback on content.
    • Efficiently process Change requests in alignment with ISO/quality/change management standards by coordinating with team members.
    • Execute production tasks following prescribed procedures and work instructions.
    • Perform inventory and quality transactions in the SAP Inventory System.
    • Complete required documentation accurately and promptly, adhering to Good Documentation Practices (GDP).

    Education and Experience

    • Bachelor's degree in science, or an Associate's degree or equivalent (preferably in a science field).
    • 1-2 years of experience in a regulated industry (experience in medical device, pharmaceutical, or biotechnology sectors preferred).
    • Familiarity with ERP systems such as SAP and Product Lifecycle Management is advantageous.
    • Basic understanding of Good Documentation Practices (GDP) is a plus.

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

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