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Sterility Assurance Technician - Sterility Testing / Microbiology Required


  • Tech Observer
  • 04/10/20
  • Montvale, NJ
  • 07645
  • tba / Hourly
  • Contractor
This is a contract opportunity for Sterility Assurance Technician located in Sinking Spring, PA

Summary:
Coordinate the day-to-day laboratory functions such as media preparation, growth, promotion, microbial identification and sterility testing of product and biological indicators.
Coordinate the environmental monitoring program.
Manage and control the inventory of laboratory reagents, supplies and biological indicators.
Schedule and coordinate the maintenance of critical laboratory equipment such as steam autoclaves, incubators, etc.
Manage, generate and organize environmental monitoring and bioburden reports which directly feed into the quality system.
Provide microbiological testing support for validation activities (facilities, manufacturing and engineering)
Review routine sterilization cycles and laboratory test results for conformance.
Maintain and develop SOPs regarding the microbiology laboratory and sterility assurance.
Develop and execute protocols related to sterility assurance, expiration dating, and sterile barrier performance.
Conducts non-conformance investigations and implementation of corrective and preventive actions
Coordinate and schedule with outside laboratories and sterilization contractors sample processing and testing to support laboratory and/or sterilization programs.
Provide validation support to facilities, manufacturing and engineering
Contributes to the completion of routine technical tasks and microbiological testing which includes but is not limited to media preparation, bioburden testing, environmental monitoring, and sterility testing.

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