Sterilization Manager Job Summary
The Sterilization Manager is responsible for ensuring compliance with applicable policies, procedures, and regulatory requirements. They must verify that their team matches the skill requirements for this role as well as associated experience.
Key Responsibilities:
* Lead and manage a team responsible for sterilization qualification of new products and changes to existing products.
* Oversee sterilization validation activities for radiation-sterilized products including dose setting and quarterly dose audits.
* Oversee sterilization validation activities for ethylene oxide (EO) sterilized products including new product qualification annual revalidations EO residual studies D-value studies.
* Serve as primary Sterilization Subject Matter Expert SME providing technical support to Product Development Operations teams
* Lead team participation in Supplier Quality audits of contract sterilization facilities third-party manufacturers.
* Spearhead investigations of EO biological indicator sterility positives ensure regulatory compliance risk mitigation.
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