Immunomedics, Inc.

  • Batch Record Supervisor

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(10/3/2019 9:54 AM)
    Job ID
    2019-1471
    # of Openings
    1
    Category
    Quality
  • Overview

    Provide Quality leadership and oversight to batch record review team and related activities. Perform and lead Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required.  This individual manages the batch documentation package and maintains records. 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. Willing to be proactive and to provide effective long-term solutions non-conformances observed. 

    Responsibilities

    • Provides Quality leadership and oversight to batch record review team.
    • Communicates batch release status to appropriate personnel.
    • Prepares Certificates of Analysis (COAs), Certificate of Compliance (COCs) or applicable lot release documentation, as required.
    • Assists in preparing Annual Reports as required.
    • Participates in audits and other projects as appropriate.
    • Supports 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.
    • Reviews and audits production batch records to ensure adherence to Immunomedics policies, SOPs, and cGMP requirements.
    • Initiates and write deviation reports and participate in activities for issue resolution as required.
    • Troubleshoot and elevate noncompliance issues and events observed.
    • Initiate and perform non-conformance investigation as required.
    • Initiate and perform corrective and preventive actions (CAPA) as required.
    • Participates 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.
    • Writes, reviews and approves Standard Operating Procedures (SOPs), as needed
    • Supports operations to encourage a Quality Culture and ensure a safe working environment.
    • Provides training and mentorship to QA specialists and manufacturing personnel as needed.
    • Completes job-related training as required.

    Qualifications

    • BS/BA in Science, Engineering, Chemistry, Biological Sciences or equivalent relevant career experience.
    • 10+ years of experience in Pharmaceuticals, Biopharma or Medical Device environment.
    • Practice knowledge and understanding of cGMPs, ICH and/or ASTM guidelines.
    • Practice knowledge and understanding of USP/EP testing or experience reviewing analytical/microbiological data.
    • 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.
    • Proactive
    • Must be proficient with MS Office applications.

     

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