Immunomedics, Inc.

  • Quality Assurance Specialist

    Job Locations US-NJ-Morris Plains
    Posted Date 4 weeks ago(9/20/2018 10:54 AM)
    Job ID
    2018-1327
    # of Openings
    1
    Category
    Quality
  • 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.

    Responsibilities

    • Provides oversight to operations on the shop 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 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.
    • 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.
    • 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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