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    UN

    Unigen

    Pharmaceutical Services

    Document Control Analyst

    Newark, United StatesOn-SiteFull-time2–5 yrs experiencePosted 4d ago
    All Unigen jobs

    Job description

    About Unigen
    Unigen is a global technology company providing innovative electronics manufacturing and product solutions to customers across diverse industries. With decades of industry experience and operations in key global markets, we combine engineering expertise, advanced manufacturing capabilities, and responsive customer service to deliver reliable, high-quality solutions—from product development through production and fulfillment.

    Location and Work Arrangement
    This position is based in Newark, California and is onsite.

    Benefits
    Unigen offers a competitive compensation and benefits package, including medical, dental, and vision coverage; a 401(k) plan; paid time off; paid holidays; and professional development opportunities. Benefits are subject to eligibility requirements and applicable plan terms.

    Job Title: Document Control Analyst
    Department: Quality / Document Control
    Reports To: Document Control Manager
    Location: Unigen Newark

    Job Overview: In coordination with internal groups, the Document Control Analyst manages documentation of engineering changes in product development, production, and validates data accuracy, integrity of documentation systems, and optimum manufacturing process.To ensure all controlled documents (BOMs, drawings, SOPs, Work Instructions, AML updates) are properly formatted, maintained, distributed, and archived in compliance with QMS/EHS and applicable requirements

    Key Responsibilities & Related Tasks

    1. Maintain and update controlled documents in PLM/ERP system
    • Upload new/updated SOPs, WIs, forms into the system.
    • Assign correct document codes and revision levels.
    • Review documents for accuracy, ensure documents meet the company’s standards and compliance with ITAR-controlled documents.

    2. Process and route Change Orders for approval

    • Collect and review for accurate data from Engineering and Program Management Teams
    • Verify completeness of change package (redlines, approvals).
    • Analyze, process and monitor Change Order submissions to minimize processing time between submission and implementation.
    • Coordinate approval and disposition/action workflows of Change Order management with stakeholders.
    • Monitor approval status and escalate delays.

    3. Validate and Modify BOM format

    • Create, analyze and release Bills of Material (BOMs)
    • Check for duplicate part numbers, reference designators, MPNs, etc.
    • Post ECN validation in ERP.
    • Verify correct unit of measure, revision, and alternates.

    Other duties and responsibilities related to Document Control as assigned.

    Required Skills & Qualifications

    1. Associate/Bachelor’s degree preferred.
    2. 2–5 years in document control.
    3. Knowledge of PLM/ERP systems and controlled document handling.
    4. Understanding BOM’s structure, PCBA and Electrical components.
    5. Proficiency with MS Office Products
    6. Strong analytical and problem-solving skills
    7. Experience working with cross functional teams
    8. Organized, self-motivated, and capable of working independently

    Job details are sourced from the employer's original posting.

    Open job posting
    UN

    About the company

    Unigen

    Unigen is a global contract research and development organization providing pharmaceutical and biotechnology services.

    View all Unigen jobs
    Industry
    Pharmaceutical Services
    Open roles
    40

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