Essential Job Duties

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.

Minimum Experience/Education

• Bachelor’s degree in Biology, Microbiology, Biotechnology, Biochemistry, Chemistry, Life Sciences, or a related scientific discipline with laboratory experience in quality control, analytical testing, or a regulated manufacturing environment.
• Equivalent combination of education and relevant laboratory experience may be considered.