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Kelly Services Microbiological Quality and Sterility Assurance SME in Warsaw, Indiana

Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Microbiological Quality and Sterility Assurance SME for a project engagement at one of our Global clients out of Warsaw, IN.

Remote Position

This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time. All KellyOCG employees receive annual performance reviews.

As a Microbiological Quality and Sterility Assurance SME placed with KellyOCG you will be responsible for the following:

Support supplier transfers as needed

Provide guidance on contamination control risk assessments

Provide guidance in the selection of worst-case master products for testing and routine monitoring

Provide guidance and review of product cleaning validations

Provide guidance and review of manufacturing and product routine monitoring programs

Provide support for manufacturing change requests


Experience with cleaning validations within the orthopedic/Medical Device industry preferred.

Preferred experience or familiarity with the following tests:

Total organic carbon (TOC), non-polar organic residues, cytotoxicity, conductivity, ion chromatography, gravimetry, bacterial endotoxin test (BET), bioburden.

Knowledge in gamma and EO sterilization, water systems, and in-process cleaning

Sterility assurance experience in the orthopedic industry preferred

Minimum of 5 years of experience required

Bachelor’s degree in engineering or related field required

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (