Quality Control & Product Development
Primapharma, Inc.
Greater San Diego Area
⦁ Liquid/Semiliquid Product/Process Development: I have worked with sprays, gels, creams, and solutions for Topical, Ophthalmic, Nasal, and Injectable use. Experience with more than 15 different drug products for IND, NDA, and ANDA applications.⦁ Analytical Chemistry work including method creation, method validation, and routine testing of raw materials, drug substances, and drug products.⦁ Incoming Material Quality Control - developed and maintained item descriptions and testing plans and performed inspection, testing, rejection, investigation, and approval functions.⦁ Developed, followed, and audited Quality System Elements for drug products and medical devices.⦁ Performed trending analysis for products, managed databases, and monitored stability study programs.⦁ Trained existing and new employees and worked with employees and management from all departments to improve manufacturing and quality system processes.