Sterilization / Microbiology Specialist

Company: Comrise
Location: Saint Paul
Posted on: May 15, 2022

Job Description:

Overview
Performs technical review of Gamma irradiation sterilization validations and proposes actions based on results of the review.
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.
Qualifications
Bachelor of Science in Microbiology, Biological sciences or similar is required.
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