Immunomedics, Inc.

  • Quality Assurance Associate

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(3 months ago)
    Job ID
    2018-1213
    # of Openings
    3
    Category
    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

    Responsibilities

    ·       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.

     

     

    Qualifications

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

             Knowledge and practical understanding of cGMPs.

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