Microbiologist I, Env. Monitoring

Hikma Pharmaceuticals USA Inc.Cherry Hill, NJ
Onsite

About The Position

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

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.

Nice To Haves

  • Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred.

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.

Benefits

  • The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors.
  • The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
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