Microbiological Quality and Sterility Assurance SME

Microbiological Quality and Sterility Assurance SME

02 Nov 2022
Indiana, Warsaw, 46580 Warsaw USA

Microbiological Quality and Sterility Assurance SME

As a Microbiological Quality and Sterility Assurance SME you will be responsible for the following:
Support supplier transfers as needed
Review contamination control risk assessments
Provide guidance in the selection of worst-case master products for cleaning validations and routine product 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

Qualifications:
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
Qualification Rating

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Job Details

  • ID
    JC22072723
  • State
  • City
  • Job type
    Contract
  • Salary
    N/A
  • Hiring Company
    Infobahn Softworld Inc.
  • Date
    2021-11-02
  • Deadline
    2021-12-31
  • Category

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