Associate Sterility Assurance Specialist

Job Summary

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.).

Job Description

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 sterilization.

• 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.

• Bachelor’s degree with a scientific or engineering background. Knowledge / Skills / Abilities - Ability to work safely in environments where hazardous chemicals may be encountered under corporate safety rules and requirements.

• Position requires travel up to 15% of the time for business purposes (within state and out-of-state).

Preferred Qualifications:

• At least 1 year relevant experience in an FDA regulated industry.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$68,640.00 - $99,320.00 Annual

This salary range is an estimate and the actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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