Immunomedics, Inc.

  • Quality Control Analyst CE Gels

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(10/16/2018 9:42 AM)
    Job ID
    # of Openings
  • Overview

    The QC Analyst performs product release and stability testing using capillary and gel-based electrophoresis methods, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.


    • Executes biochemical and chemistry release and stability testing using electrophoresis-based methods following SOPs and records data in a GMP compliant manner
    • Supports release and stability testing using routine analytical techniques (e.g., concentration analysis by A280) as needed based on laboratory demand.
    • Performs preventative maintenance and/or calibration activities, purchasing, receiving. Assumes responsibility for cleanliness and orderliness of work area and other laboratory maintenance duties as assigned.
    • Participates in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
    • Participates in method validation of simple / complex analytical methods commensurate with experience and qualification of laboratory equipment as assigned
    • Participates in laboratory investigations and performs CAPA activities as assigned
    • Maintains required training and training records and provides training to qualify other Laboratory Associates.
    • Familiarity with analytical capillary and gel-based methods used for purity and impurities testing for release and stability of biopharmaceutical products
    • Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
    • Must be able to work in a team environment and perform job responsibilities under supervision. 
    • Experience with receipt and testing of product samples, ability to provide technical support to the testing lab.
    • Experience with development, transfer and implementation of analytical method validation based on FDA and ICH guidelines is desirable.


    Associate’s Degree and a minimum of 3 years’ experience in chemistry, biology, pharmaceutical science or a Bachelor’s Degree and a minimum of 1 year of applicable GMP laboratory experience is required.


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