Immunomedics, Inc.

  • Quality Assurance Associate, Raw Material Release and Clinical Shipments

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(3/8/2018 4:14 PM)
    Job ID
    # of Openings
    Scientific Manufacturing/Production
  • Overview

    We are seeking a Quality Assurance Associate to be responsible for all QA-related aspects of material handling, storage, shipping and control, and associated documentation.  This position may also be cross-trained on product disposition and regulated document/training functions.


    • Quarantine materials, inspect shipments, examine Certificates of Analysis (COAs), review test results, determine release status, and manage all raw materials documentation
    • Coordination of clinical shipments
    • Preparation and circulation of controlled documents (e.g., specifications, labels)
    • Inventory management
    • Stability data review
    • Generation of associated reports
    • Conduct changeovers in production area as required
    • 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 raw material release and clinical shipments functions strongly preferred
    • Excellent written and verbal communication skills required; scientific writing experience a plus
    • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a fast-paced, timeline-driven environment necessary
    • Must be proficient with MS Office applications
    • Ideal candidate will possess a strong customer service philosophy 


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