Sterilization Associate

Duties:

This position is responsible for performing a sterility assurance function with its primary purpose to develop, validate and monitor product sterilization processes in accordance with industry standards. This is accomplished through a wide variety of duties which support new product development, manufacturing operations, implant/instrument sterilization, and special projects in the Environmental/Microbiology Services Laboratories.
Principal Duties and Responsibilities
%
15
§
Reviews routine sterilization records and performs sterility release for sterile implants
15
§
Assists in the review and classification of new and modified products
15
§
Assists in the execution of validation and process improvement projects
15
§
Executes special projects in the Environmental/Microbiology Services Laboratories
15
§
Represents Sterilization Technology Department on cross function teams to address manufacturing issues, cleanroom issues, new product development, nonconforming product investigations, etc.
10
§
Educates department personnel, manufacturing personnel, and development personnel on concepts in instrument reprocessing and industrial sterilization
5
§
Assists with and/or prepares departmental documentation (Client Work Instructions, test protocols, validation documents, technical reports, etc.) for review and approval
5
§
Provides technical guidance to internal and external customers on issues pertaining to microbiology, clean room technology, instrument reprocessing, and industrial sterilization
5
§
Represents Client as an alternate on AAMI Standards Committees.
100
Total Percent (not to exceed 100%)
*Individual percents should be greater than or equal to 5%.

Skills:
This position is responsible for performing a sterility assurance function with its primary purpose to develop, validate and monitor product sterilization processes in accordance with industry standards. This is accomplished through a wide variety of duties which support new product development, manufacturing operations, implant/instrument sterilization, and special projects in the Environmental/Microbiology Services Laboratories.
Principal Duties and Responsibilities
%
15
§
Reviews routine sterilization records and performs sterility release for sterile implants
15
§
Assists in the review and classification of new and modified products
15
§
Assists in the execution of validation and process improvement projects
15
§
Executes special projects in the Environmental/Microbiology Services Laboratories
15
§
Represents Sterilization Technology Department on cross function teams to address manufacturing issues, cleanroom issues, new product development, nonconforming product investigations, etc.
10
§
Educates department personnel, manufacturing personnel, and development personnel on concepts in instrument reprocessing and industrial sterilization
5
§
Assists with and/or prepares departmental documentation (Client Work Instructions, test protocols, validation documents, technical reports, etc.) for review and approval
5
§
Provides technical guidance to internal and external customers on issues pertaining to microbiology, clean room technology, instrument reprocessing, and industrial sterilization
5
§
Represents Client as an alternate on AAMI Standards Committees.
100
Total Percent (not to exceed 100%)
*Individual percents should be greater than or equal to 5%.