Insulet Corporation

  • Microbiologist

    Job Locations US-MA-Acton | US-MA-Acton
    Posted Date 1 month ago(1/14/2019 1:03 PM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    This position will be critical to supporting Insulet’s Global Sterility Assurance program.  The Microbiologist role will primarily work within the QA Sterilization/Microbiology group performing various microbiological testing, including sample collection, bioburden testing, bacterial endotoxin testing, and environmental monitoring.  This position will also support laboratory equipment qualifications, contract sterilization, and sterilization/test method validations. 

    Responsibilities

    • Perform environmental monitoring of manufacturing areas (viable air, viable surface, and non-viable particulate testing).
    • Perform product bioburden and bacterial endotoxin testing.
    • Conduct quality control acceptance testing of microbiological media.
    • Use standard laboratory equipment including pH meters, microplate readers, balances, incubators, chart records, autoclaves, depyrogenation ovens, microscopes, vortexers, filtration systems, particle counters, air samplers, and pipettes.
    • Accurate completion of test records and documents for tests performed, as well as accurate computer data entry.
    • Support generation of procedures/work instructions related to sterility assurance.
    • Support microbiology laboratory investigations. Support activities related to microbiology nonconformances and CAPAs.
    • Perform routine sterilization record review. Support activities related to sterilization nonconformances and CAPAs.
    • Generate protocols and reports for sterilization qualifications and test method validations.
    • Conduct laboratory equipment qualifications, calibration, and preventive maintenance (as applicable).
    • Support quality audits, as required.

     

     

    Education and Experience

    Minimum Requirements:

    • Bachelor’s Degree in Microbiology or related field with a minimum of 3 years relevant experience.
    • Prior experience working in the medical device or similar FDA-regulated industry is strongly preferred.

    Preferred Skills/Competencies:

    • Must be proficient with general computer skills and Microsoft applications, specifically Word and Excel. Experience with statistical software programs like MiniTab is preferred.
    • Effective verbal communication and organizational skills.
    • Effective technical writing capability.
    • Must demonstrate great attention to detail and have ability to work efficiently.
    • Experience with basic microbiological laboratory techniques, including aseptic technique, and environmental monitoring.
    • Working knowledge of EO sterilization is strongly preferred.

    Physical Requirements:

    • Ability to lift up to 10 pounds.

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