Immunomedics, Inc.

  • QC Senior Analyst

    Job Locations US-NJ-Morris Plains
    Posted Date 5 days ago(10/11/2018 1:42 PM)
    Job ID
    2018-1349
    # of Openings
    1
    Category
    Quality
  • Overview

    The QC analyst is responsible for routine testing of incoming raw materials for release and utility samples testing. The incumbent will be supporting raw materials and adventitious virus safety testing of bioreactor harvests at third party provider. This position also include responsibility of authoring technical reports, specifications for incoming raw materials and evaluation of change notifications, as directed by the group manager

    Responsibilities

    • Works in a cGMP QC laboratory setting, responsible for utility testing and raw material testing in house and supports testing at a third party provider (TPP). Ensures timely delivery of test results to meet deadlines for release of raw materials, and process intermediates.
    • Accountable for maintenance performance of instrumentation and documenting any routine or preventative maintenance in the system.
    • Effectively participates validation and technical transfer of analytical methods in compliance with FDA, compendia and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.
    • Participates in implementation of spectroscopy based identity testing for incoming raw materials and other analytical method development activities, both inhouse and at TPP
    • Participates in change managements, laboratory investigations, GAP analyses

    Qualifications

    • Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines
    • Ability to work in a team environment and perform job responsibilities under minimal supervision
    • Working knowledge of analytical methods for raw material testing, compendial affairs, wet chemistry, spectroscopic methods.
    • Must have familiarity with technical/analytical content of clinical and commercial regulatory submissions and be able to maintain analytical testing and laboratory facilities in compliance with regulatory expectations.
    • Some experience with development, transfer and implementation of analytical method validation based on FDA and ICH guidelines.

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