UTS - Temporary Quality Control Analyst at UNC Chapel Hill
About The Position
The Quality Control Analyst is responsible for performing and supporting Quality Control testing activities related to sterility, bioburden, release testing, stability testing, and analytical development. This position executes laboratory testing procedures, analytical validations, and data review activities to support the manufacturing and release of patient products while ensuring compliance with FDA requirements, Good Documentation Practices (GDP), and established quality standards. The Quality Control Analyst supports new product onboarding, develops and maintains testing procedures, assists with investigations, performs statistical analysis of results, and provides guidance and training to QC employees on testing methods and processes.
Requirements
- Experience with sterility testing.
- Experience with bioburden testing.
- Experience with release testing.
- Experience with stability testing.
- Experience with analytical development.
- Ability to execute laboratory testing procedures.
- Ability to perform analytical validations.
- Ability to perform data review activities.
- Knowledge of FDA requirements.
- Knowledge of Good Documentation Practices (GDP).
- Knowledge of established quality standards.
- Experience with new product onboarding.
- Ability to develop and maintain testing procedures.
- Ability to assist with investigations.
- Ability to perform statistical analysis of results.
- Ability to provide guidance and training to QC employees on testing methods and processes.
Responsibilities
- Performing and supporting Quality Control testing activities related to sterility, bioburden, release testing, stability testing, and analytical development.
- Executing laboratory testing procedures, analytical validations, and data review activities to support the manufacturing and release of patient products.
- Ensuring compliance with FDA requirements, Good Documentation Practices (GDP), and established quality standards.
- Supporting new product onboarding.
- Developing and maintaining testing procedures.
- Assisting with investigations.
- Performing statistical analysis of results.
- Providing guidance and training to QC employees on testing methods and processes.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
