Immunomedics, Inc.

  • Quality Assurance Specialist Raw Materials

    Job Locations US-NJ-Morris Plains
    Posted Date 4 days ago(4/17/2019 1:39 PM)
    Job ID
    2019-1427
    # of Openings
    1
    Category
    Quality
  • Overview

    Responsible for Quality oversight for the warehouse and raw material release. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations in the warehouse. Assure that raw material released complies with all applicable regulations and guidelines.

    Responsibilities

    • Provides QA oversight to operations in the warehouse, supply chain and raw material testing.
    • Reviews raw material files for release.
    • Communicates release status of raw materials to appropriate personnel.
    • Maintains appropriate records.
    • Maintains and supports material inventory, status and transfers.
    • 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.
    • Supports and performs Raw Material Disposition
    • Initiate deviation reports and participate in activities for issue resolution.
    • Participate in process improvement initiatives targeting for Right First Time (RFT) on documentation.
    • Provide guidance to warehouse staff of appropriate regulations and Immunomedics quality standards.
    • Communicate with suppliers for any missing documents or raw material issues.
    • 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
    • Prepare metrics for QA management related to raw material
    • 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.
    • 3-5 years of experience in a Pharmaceuticals environment.
    • Practice knowledge and understanding of cGMPs.
    • Biologics manufacturing experience or knowledge a plus
    • 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.
    • Proficient in MS Great Plains software

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