Position Overview

Leads multiple quality assurance projects and activities to support the sterility and pyrogenicity requirements of medical products. Job duties:
  • Manages microbiological testing performed in-house and by outside laboratories.
  • Works with new product validation for steam, heat, radiation, and ethylene oxide sterilization.
  • Coordinates cleanroom microbial and particulate testing.
  • Coordinates pyrogen testing validation.
  • Coordinates Bioburden and Sterility test.
  • Coordinates Compressed Air annual validation.
  • Coordinates Requalification of the Action/Alert Levels.
  • Performs other duties or responsibilities as assigned.
    1. Bachelor’s Degree in related field or equivalent; advanced degree a plus.
    2. Minimum of seven (7) years of related experience.
    3. Good communication skills.
    4. Past leadership or supervisory experience.
    Desired Qualifications
    1. Excellent command of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring.
    2. Working knowledge of various sterilization processes including steam, heat, radiation, and ethylene oxide.
    3. Working knowledge of sterilization and pyrogen testing, microorganism identification and skill performing sterilization product release testing on biological indicators.
    4. Experience with parametric release validations and requirements.
    5. Skill determining root causes of unanticipated high microbial or pyrogen levels on products.
    6. Expertise setting up a microbiology testing laboratory with the ability to specify and procure equipment and supplies for in-house sterility testing.
    7. Good command of appropriate laboratory practices.
    8. Successful track record training and supervising staff performing microbiological testing.
    9. Past experience participating in audits to assure compliance with FDA, ISO and other requirements.