Immunomedics, Inc.

  • QC Sample Coordination Technician

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(6/25/2018 9:40 AM)
    Job ID
    2018-1220
    # of Openings
    1
    Category
    Quality
  • Overview

    The primary purpose of this position is to provide support to the sample management group in a QC laboratory setting in support of commercial manufacturing, collate and organize lot release data, track sample custody and cold chain management.  Activities include equipment maintenance, coordinate and track the status of internal external batch release testing, receipt of test results.

    Responsibilities

    • Following departmental SOPs, coordinate with internal Manufacturing / QC to perform receipt of samples. Perform supporting sample preparation activities as needed, accurately document all activities performed.
    • Process and distribution of samples to internal QC labs, prepares samples for shipment for offsite testing, ensure sample integrity and chain of custody is thoroughly documented.
    • Coordinate receipt of completed test results, collate and submit for management review and release.
    • Provide support for the QC retains program, including inventory management and periodic inspection.
    • Perform preventative maintenance and/or equipment monitoring activities, coordinates and schedules equipment maintenance / calibration activities with a third-party provider as needed.
    • Monitor the inventory of lab supplies and materials, order as needed.
    • Perform other duties as required, work closely with Management regarding work scheduling and assignments. Coordinate outside contract testing.
    • 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.
    • Participate in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
    • Individual may be called upon to perform additional tasks as assigned by supervisor, off hours, weekend or Holiday hours may be required.
    • Maintain required training and training records.
    • Exceptional attention to detail in documentation, good organizational and time management skills.
    • Good oral and written communication for effective interpersonal collaboration, with ability to multitask while working under restrictive timelines.
    • Ability to work in a team environment and perform job responsibilities with reasonable supervision.
    • Knowledge of analytical methods currently used for release and stability testing of biopharmaceutical products.
    • Fluency in statistical trend analysis software applications, Windows and Microsoft Office

    Qualifications

    Minimum of a High School education and 5 years’ work experience in a cGMP manufacturing or testing environment or an Associate’s Degree and a minimum of 2 years’ experience in same or a Bachelor’s Degree in a scientific discipline is required.

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