Immunomedics, Inc.

  • Validation Specialist

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(5/24/2019 1:55 PM)
    Job ID
    2019-1446
    # of Openings
    1
    Category
    Validation
  • Overview

    Creates, reviews, and revises technical documentation of procedures and practices associated with the Validation department. Ensures appropriate maintenance of technical documents, provides various support, and coordinates activities for the Validation department.

    Responsibilities

    • Develop, implement and manage validation deliverables to ensure equipment, facilities and utilities meet appropriate regulatory validation requirements, internal company standards and current Good Manufacturing Practices (cGMP).
    • Author revisions to Validation procedures as required.
    • Document control tasks, such as issuing Validation document numbers, scanning and logging documents
    • Coordination of Quality Management System (QMS) driving to closure of open items. Specifically, track and communication all implementation steps and status of corresponding deliverables.
    • Ability to multi-task including support of unanticipated urgent issues requiring expedited turnaround.
    • Triage issues related to Validation deliverables and liaise with cross-functional stakeholders to resolve.
    • Perform other duties as required and available for

     

    Qualifications

    • Work experience in regulated industry (biologics, pharma, medical device)
    • Work experience with EDMS in a document control role. Veeva preferred, but not required.
    • Bachelor’s degree with 4 years experience or equivalent
    • Computer competency, including Microsoft Word, Excel, Visio, Flow Charts.
    • Excellent reading and writing skills.
    • Excellent organization skills and attention to detail.

     

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