Sterility Assurance Specialist

6 days ago


King of Prussia, Pennsylvania, United States Proclinical Staffing Full time
Job Title: Microbiologist

We are seeking a skilled Microbiologist to join our team at Proclinical Staffing. As a Microbiologist, you will be responsible for performing Quality Control and Sterility Assurance activities in a sterile product environment.

Key Responsibilities:
  • Perform environmental monitoring to support non-sterile and sterile areas of the facility.
  • Conduct routine bioburden testing on raw materials and finished products.
  • Perform bacterial endotoxin testing on pharmaceutical water system samples, raw materials, and finished products.
  • Identify microbial isolates and enter results in the electronic documentation system.
  • Ensure all necessary testing is performed and evaluated against applicable procedures.
  • Successfully gown qualify to perform sterility assurance and routine activities in Grade B areas of the facility.
Requirements:
  • Bachelor's degree in Microbiology or related science.
  • Recent experience in aspects of sterility assurance, including gowning and investigations.
  • Good communication skills and ability to work effectively with a team.
  • Knowledge of cGMP requirements and ability to generate high-quality data.
  • Computer application experience, including database use and management.
  • At least 3 years of practical laboratory experience.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. We are an equal opportunity employer.



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