Immunomedics, Inc.

  • Quality Control Analyst CE Gels

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(10/16/2018 9:42 AM)
    Job ID
    2018-1350
    # of Openings
    1
    Category
    Quality
  • 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.

    Responsibilities

    • 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.

    Qualifications

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed