Immunomedics, Inc.

  • Quality Assurance Associate

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(3 months ago)
    Job ID
    # of Openings
    Scientific Manufacturing/Production
  • Overview

    Provide Quality assistance and oversight during manufacturing of in-process upstream and downstream, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.


    Note: Temporary Assignment with Potential to become Permanent


    ·       Provides QA oversight to operations on the floor.  Support manufacturing operations (upstream and downstream) at real time.

    ·       Performs routine manufacturing batch production record review in support of product release in accordance with cGMPs, specifications and SOPs.

    ·       Support manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.

    ·       Reviews documentation associated with production operations.  Ensures adequate levels of documentation are acceptable and cGMP compliant to existing procedures.

    ·       Review and audit production batch records to ensure adherence to Immunomedics policies, SOPs and cGMP requirements.

    ·       Provide support to QA Batch Release to assist with batch record release and compliance issues.

    ·       Initiate deviation reports and participate in activities for issue resolution and CAPAs.

    ·       Participate in process improvement initiatives targeting for Right-First-Time (RFT) on documentation.

    ·       Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to implement corrective actions.

    ·       Implements and ensures adherence of appropriate cGMP regulations and Immunomedics quality standards.

    ·       Write, review and approve Standard Operating Procedures (SOPs), as needed.

    ·       Support operations to encourage a Quality Culture and ensure a safe working environment.

    ·       Complete job-related training as required.




    • BS/BA in Biological Sciences or equivalent relevant career experience.
    • 3 + years of experience in a Pharmaceuticals environment.

             Knowledge and practical understanding of cGMPs.


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