Immunomedics, Inc.

  • QC Analyst/ Senior Analyst-HPLC

    Job Locations US-NJ-Morris Plains
    Posted Date 4 weeks ago(9/20/2018 12:09 PM)
    Job ID
    2018-1329
    # of Openings
    1
    Category
    Quality
  • Overview

    The QC Analyst performs routine product release and stability testing using HPLC and UPLC, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.

    Responsibilities

    • Executes routine biochemical and chemistry release and stability testing using HPLC and UPLC 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.
    • Participates in validation and technical transfer of analytical methods commensurate with experience.
    • Performs timely and accurate peer review of analytical test results reports.
    • Performs preventative maintenance and/or calibration activities or coordinates and schedules these activities with a third-party provider. Responsible for cleanliness and orderliness of work area, maintains the laboratory in a state of inspection readiness and performs 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 laboratory investigations and root cause assessment and performs CAPA activities as assigned
    • Maintains required training and training records and provides training to qualify other Laboratory Associates.

    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 3 years of applicable GMP laboratory experience is required.
    • 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 with minimal supervision.

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