Immunomedics, Inc.

  • Change Control Manager

    Job Locations US-NJ-Morris Plains
    Posted Date 4 days ago(12/5/2018 9:25 AM)
    Job ID
    2018-1379
    # of Openings
    1
    Category
    Quality
  • Overview

    This position requires expertise in pharmaceutical drug development and manufacturing sectors, with strong emphasis in cGMP documents in compliance with FDA regulations 21CFR Parts 210, 211, and 610. In-depth experience in change control, investigation Quality Systems.  familiar with  analytical/bioassay stability laboratory test methods, instrument qualification, and  method validation

    Responsibilities

    • Manage staff of 2-3 professionals.
    • Manage Change Control quality system program by review and revising the appropriate procedures, and processes.
    • Author and approve Standard Operating Procedures, ports and Specifications
    • Guide, and train the organization in change control process and evaluate change control documents for completeness
    • Collaborate and participate in review of validation documents such as protocol and summary reports, technology transfer, reference standard qualification.
    • Review of specification, stability protocols, method validations.
    • Prepare Annual Product Report (APR)
    • Familiar with electronic data systems preferably Veeva
    • Be familiar with quality analytical, bioassay, analytical method development and method suitability.
    • Familiar with laboratory operations processes including in-process, release and stability testing of raw materials (proteins), intermediate and finished biological products.
    • Familiar with biological /aseptic manufacturing
    • Familiarity with equipment and process validation is desirable
    • Align training, development of personnel and succession plan. Update and maintain training documents.
    • Implement Quality Systems, including Quality Manual, in-house/CRO Deviation Management, Change Control, Corrective and Preventive Action (CAPA).
    • Sustain Contract Research Organization (CRO) quality contracts.

     

    Qualifications

    • Bachelor of Science, Biology
    • Master’s Degree a plus
    • SOP, Deviations, OOS Investigation, CAPA, Project management, Veeva, ComplianceWire, Microsoft Excel, Microsoft Access and knowledge of LIMS. 

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed