West-Ward Pharmaceuticals

  • Quality Lab Assoc I (EM)

    Job Location US-NJ-Cherry Hill
    Posted Date 1 month ago(5/23/2018 2:22 PM)
    Job ID
    2018-4547
    Job Function
    Quality
    Shift
    2nd
  • Overview

    This is a position located in Cherry Hill, NJ on 2nd Shift

     

    Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas.  The duties also include equipment maintenance and LIMS management.

    Responsibilities

    • Ensure Environmental Monitoring (EM) of the facility’s controlled areas is performed as required.
    • Document EM testing into the EM database prior to incubation, ensure samples are correctly incubated, and record sample results in the EM database following incubation.
    • Compile trending data for EM testing to support investigations.
    • Audit personnel aseptic technique in controlled areas including during process simulations (media fills).
    • Author laboratory event and investigation reports.
    • Communicate issues between departments as appropriate.
    • Communicate effectively with co-workers to ensure all required tasks are completed as expected.
    • Document test data clearly and accurately. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.

    Qualifications

    • BS/BA Degree in Microbiology or Biology with 0-2 years
    • pharmaceutical microbiology experience. Microbiology coursework and laboratory work utilizing aseptic technique is required.
    • Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification
    • Must be able to lift 20 lbs
    • Ability to handle multiple tasks concurrently and complete tasks in a timely fashion.
    • Computer literate.
    • Must be able to communicate effectively across all departments and levels of management.
    • Must have understanding of laboratory instruments and methods.
    • Must have excellent writing skills to write clear and concise reports.
    • Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred.

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