Quality Lab Associate I, Env. Monitoring

Job Description

Posted on: 
December 6, 2023

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


  • 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.

Job Requirements

  • 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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