Lead Sterility Assurance Specialist

6 days ago


King of Prussia, Pennsylvania, United States Alphanumeric Systems Full time
About the Role

We are seeking an experienced Senior Microbiologist to join our team at Alphanumeric Systems in Upper Merion, King of Prussia, PA. This role is a crucial part of our Quality Control and Sterility Assurance activities.

Key Responsibilities
  • Perform Environmental monitoring to support non-sterile and sterile areas of the facility.
  • Routine bioburden testing on raw materials and finished product.
  • Bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products.
  • Identification of microbial isolates.
  • Entering results in the electronic documentation system.
  • Ensuring that all necessary testing is performed and evaluated against applicable procedures.
Requirements
  • Bachelor's degree in Microbiology or related science.
  • Demonstrated abilities and experience as a microbiologist in a sterile product Quality Control role.
  • Recent experience in aspects of sterility assurance including gowning and investigations.
  • Good communication skills.
  • Ability to work effectively with a team and independently.
  • Knowledge of cGMP requirements.
  • High-quality data generation skills.
  • Computer application experience (database use and management).
Estimated Salary Range

$80,000 - $110,000 per year, depending on experience.



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