Immunomedics, Inc.

  • Quality Assurance Associate, Product Disposition

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(3/8/2018 2:58 PM)
    Job ID
    # of Openings
    Scientific Manufacturing/Production
  • Overview

    We are seeking a Quality Assurance Associate to be responsible for the Product Disposition function, encompassing the review of production batch records and associated documentation required to release a production lot.  This individual manages the batch documentation package and maintains records.  This position may also be cross-trained on the Raw Material Release/Clinical Shipments and Regulated Document/Training functions.


    • Review production batch documentation package for lot release. 
    • Communicate release status to appropriate personnel. 
    • Prepare, revise, and maintain Certificates of Analysis (COAs).
    • Maintain controlled records.
    • Review Process Simulation (media fill) system as required.
    • Conduct changeovers in production area as required. 
    • Inventory management.
    • Stability Data Review.
    • Participate in audits, investigations, corrective action/preventive action (CAPA), standard operating procedure (SOP) preparation/revision/review, and other projects as appropriate.
    • Participate in issue resolution and identify opportunities for process/system improvement.


    • Bachelor’s degree in biology, chemistry, or related field, with 1-3 years of prior GxP experience in a biotechnological, pharmaceutical, or clinical environment; or equivalent combination of education and experience. 
    • Background/familiarity in product disposition, batch record review, and/or raw material release strongly preferred.
    • Excellent written and verbal communication skills required, including Responsible Business Communication; scientific writing experience a plus.
    • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
    • Must be proficient with MS Office applications.
    • Ideal candidate will possess a strong customer service philosophy. 


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