Job Description

• Monitoring of Classified Areas using
  • Active/passive air sampling methods and RODAC/swab surface sampling methods for the detection of bacteria and fungi
  • CliMet air sampling methods for the detection of Total Particulates; trending of this data to detect anomalies, and characterize the transient and resident microflora.
• Utilities –Testing of
  • City water for total microbial count and the absence of enteric organisms;
  • Pre-treat water, clean steam and Water for Injection for total microbial count and presence of endotoxins; and
  • Nitrogen and process air for total microbial count and total particulates.
  • Utilizes classical microbiological methods for the identification of microorganisms.
  • Perform validation activities such as biological indictor recovery, bioburden rinse/swab, endotoxin rinse and endotoxin challenge vial testing.
  • Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS).GMP Documentation – Document test results and conclusions in a GMP manner. 
  • Ensure test forms are complete before submission for approval.   
  • Performs responsibilities in compliance with company quality systems.
  • Adheres to all company safety, health and environmental policies, procedures and directives.
  • Conducts all laboratory activities in a safe manner by use of MSDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel

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