Lead Sterility Assurance Specialist
6 days ago
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.
- 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).
$80,000 - $110,000 per year, depending on experience.
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