Sterilization / Microbiology Specialist
Location: Saint Paul
Posted on: May 15, 2022
Performs technical review of Gamma irradiation sterilization
validations and proposes actions based on results of the
This review is performed to ensure historical sterilization
validations conform to EU MDR requirements. Perform sterilization
validations in the event historical sterilization validations are
inadequate to comply to EU MDR requirements.
Reads and interprets microbiological cultures and other related
tests including but not limited to environmental monitoring,
sterility tests, growth promotion, microbial limits tests and
antimicrobial effectiveness tests.
May perform validation, technology transfer and troubleshooting,
and write policy procedure for quality initiatives.
Reviews and approves environmental monitoring data and laboratory
equipment and records.
Prepares process and status reports, assigns and monitors document
numbers and reviews documents for accuracy and completeness.
Bachelor of Science in Microbiology, Biological sciences or similar
7+ years of experience in working with Gamma Irradiation
sterilization of class III implantable medical devices.
This position is fully remote.
Keywords: Comrise, St. Paul , Sterilization / Microbiology Specialist, Other , Saint Paul, Minnesota
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