Job: Microbiologist

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Posted: 07/24/2017

Job Status: Full Time

Job Reference #: 14038

Job Description

Summary

Performs microbiological testing on raw materials, in-process and finished product as well as environmental samples in a cGMP/GLP laboratory.  Assists in OOS investigations and excursions reports.

Duties & Responsibilities

  • Performs routine microbiological testing on raw materials, in-process and finished products using compendial methods such as USP, AOAC, FDA-BAM and in-house validated methods on the rapid automated Biolumix system.
  • Performs retesting of out-of-specification (OOS) results, assists with OOS investigations and OOS reports as directed by micro Supervisor.
  • Performs water sampling at various ports and perform bioburden, TOC and conductivity testing.
  • Performs Environmental Monitoring testing (for air and surface) per established protocol.
  • Reviews water and EM test results and assists in investigation of excursions and preparation of relevant reports as directed by micro Supervisor.
  • Documents and reports results in the appropriate notebooks and databases.
  • Prepares media used for the microbiological analysis of samples.
  • Performs timely cleaning and disinfection and handling of biohazard and general wastes.
  • Maintains supplies and media inventory for the micro lab in collaboration with the Lab Coordinators by creating needed Purchase Requisitions Forms and formally qualifying received media and reagents.
  • Operates, maintains and ensures calibration of equipment including thermometers, analytical balances, pipettes and other related equipment used in the micro lab; notifies micro supervisor of potential issues.
  • Assists with new equipment qualification/ validation projects as directed by Micro Supervisor / Manager.
  • Assists in developing or revising microbiological test methods.
  • Trains and mentors Associate Microbiologists and Micro Technicians
  • Reviews and revises Standard Operating Procedures (SOP) as directed by Micro Supervisor
  • Assists in implementing cGMP/GLP programs and procedures within the micro laboratory.
  • Complies with cGMP, cGLP, FDA and other applicable industry regulations as well as NAI policies

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