Quality Control Analyst
Duties and Responsibilities:
• Develop and validate the analytical methods for the release and stability testing of clinical-grade and commercial-grade radiopharmaceuticals.
• Perform QC release and stability testing (e.g., pH, HPLC, GC, sterility, bacterial endotoxin test, bioburden, etc.) of radiopharmaceuticals for clinical and commercial use according to cGMP standards.
• Perform release testing according to SOPs on other materials (e.g. raw materials for radiopharmaceutical production).
• Generate and maintain accurate testing records and test/validation results.
• Bachelor’s degree in a scientific related discipline (e.g. Chemistry, microbiology)
Technical Skills Required:
• 3+ year experience in a commercial pharmaceutical development or manufacturing analytical laboratory
• Knowledge of GMP/GLP principles
• Knowledge of safety procedures for hazardous environment (chemical and radioactive)
• Knowledge of cGMP laboratory controls and analytical method development and validation