Associate Sterility Assurance Specialist - Redmond, OR

Medline•Redmond, OR

1d•Onsite

About The Position

Prepare and execute sterilization related activities for medical device and pharmaceutical products. Support various Medline product divisions while assuring appropriate sterility assurance levels to comply with FDA regulations and ISO standards (e.g. 21 CFR Part 820/211, IS011135, ISO11137 etc.).

Requirements

Bachelor’s Degree in life sciences or engineering.
At least 1 year relevant experience in an FDA regulated industry.
Ability to work safely in environments where hazardous chemicals may be encountered under corporate safety rules and requirements.

Nice To Haves

2-4 years of work experience in sterilization may be accepted in lieu of a degree.

Responsibilities

Prepare items for sterility, bioburden, and residual testing.
Maintain sterilization files and document libraries.
Prepare validation protocols and reports.
Order validation test samples and ensure accurate shipping.
Prepare purchase order and test request for testing of the validation samples.
Review test results, run records, analyze temperature and humidity data to ensure correct acceptance criteria and prepare final reports for approval.
Assign sterilization cycles to new products based on review of materials, product construction, and packaging.
Review the validated process to confirm item can be sterilized in this process.
Review sterilization process deviations and work with division QA to determine product disposition.
Provide instructions to the sterilization facility for re-processing and any additional evaluation required prior to final release.
Review and revise sterilization-related procedures as needed when a new sterilization process is added or there is a change in current process.
Provide onsite assistance as needed during validation preparation and train contract sterilization vendors on preparation of validation loads.