Immunomedics, Inc.

  • Document Control Associate (Contract)

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(4/3/2019 12:06 PM)
    Job ID
    2019-1414
    # of Openings
    2
    Category
    Quality
  • Overview

    Provide daily Documentation support to laboratory and operation by:

     

    • Maintenance of Standard Operating Procedures,
    • Support printing control forms, issuance of controlled logbook,
    • Storage and archival of control documents and maintenance of Documentation Control Rooms
    • Maintenance of Veeva Documentation system,
    • Issuance of batch record, control number and part number
    • Provide support during regulatory inspection
    • Process Document change controls and Document change orders
    • Provide cross training to team members

    Responsibilities

    • Independently performs day-to-day Document Control activities.
    • Process document control forms and SOPs, review for correctness and completeness.
    • Monitor and update in-process documents.
    • Create, assign and archive controlled logbooks.
    • Process Document Change controls in electronic document management system (Veeva).
    • Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval.
    • Provide support during regulatory inspections.
    • Implements and ensures adherence to appropriate regulations and Immunomedics quality standards.
    • Write, review and approve Standard Operating Procedures (SOPs), as needed.
    • Complete job-related training as required.

    Qualifications

    • BA in English, psychology, technical writing or equivalent relevant career experience.
    • Practical knowledge and understanding of cGMPs.
    • 5 + years of experience in a Pharmaceuticals/Biotech or medical device environment administering Document Control Systems.

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