Duration: Will be working on a project basis, each project will be sent over and an estimated number of hours will be agreed upon.
Start Date: ASAP
1. Annual Gamma Sterilization Family Review
2. Annual Steam Sterilization Family Review
3. Bioburden change review (closely related to 1)
4. Redline updates to clean room SOP(s) for standards compliance (gap assessments for ISO 14644 & ISO 17141)
5. Review and evaluation of microbial identification data
6. Review and evaluation of CEA excursions/limit violations
Skills: Clean Room, Gamma Sterilization, Steam Sterilization, Bioburden Testing, Microbiology, ISO 14644, ISO 17141
Education: Experience outweighs degree.