Immunomedics, Inc.

  • QA Specialist

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(11/1/2018 2:51 PM)
    Job ID
    2018-1358
    # of Openings
    1
    Category
    Quality
  • Overview

    The Quality Assurance Specialist focuses on 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 for Raw Material Disposition, Clinical Shipments support and to provide oversight to operations on the manufacturing shop floor.

    Responsibilities

    • Reviews production batch documentation package for batch release.
    • Communicates release status to appropriate personnel.
    • Maintains appropriate records.
    • Maintains and supports material inventory, status and transfers.
    • Performs and supports changeovers in production area as required.
    • Prepares Certificates of Analysis (COAs).
    • Assists in preparing Annual Reports as required.
    • Revises SOPs as required.
    • Participates in audits and other projects as appropriate.
    • Supports and performs Raw Material Disposition, as needed.
    • Supports and performs Clinical Shipments, as needed.
    • Provides oversight to operations on the shop floor as needed.
    • Performs routine manufacturing batch production record review in support of product release in accordance with 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 compliant to existing procedures.
    • Review and audit production batch records to ensure adherence to Immunomedics policies, SOPs, and cGMP requirements.
    • Initiate deviation reports and participate in activities for issue resolution.
    • 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
    • Implements and ensures adherence of appropriate 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.
    • Practice knowledge and understanding of cGMPs.
    • Excellent written and verbal communication skills required, including Responsible Business Communication.
    • 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.

     

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