Rae L Martin Email & Phone Number

Over 25 years of hands-on and management experience in Product Development, Process Development, Regulatory Compliance, Quality Assurance, Quality and Safety System Develoopment and Implementation, and Project Management in the Dietary Supplement, Food, Cosmetics, and OTC Pharmaceutical Industries. An FSPCA lead instructor of Food Safety and Preventive Control (An FDA-recognized program). Global Product Development from Concepts to Commercialization – Lead cross-functional product development teams to develop and launch products from concepts, formulation, prototypes, regulatory review, claim development and substantiation, specifications development (ingredients, products, and process control), testing method development, R&D scale-up, production scale-up and verification, supplier and contract manufacturer qualification and verification, to technology transfer. Global Product Registration and Product Filing – Work with government agencies and outside consultants, and internal cross-functional teams to register and file food, dietary supplement, and cosmetics products in the US, China, Southeast Asia, Canada, and other countries. Quality Systems Development and Implementation - cGMPs (Dietary Supplement, Food, Cosmetics, OTC, etc.), GLP, and GCP Food Safety Systems Development and Implementation - FSMA, FSVP, HACCP, SQF, GFSI, etc.  Regulatory Compliance – Correspond with FDA to resolve 483s and warning letters, file GRAS and NDI Notifications, perform labeling review, etc. Quality Assurance – Develop corporation quality policy, develop and implement SOPs and process controls, conduct supplier audits, prepare for FDA/customer/certification audits, develop and implement corrective actions and preventive actions (CAPAs), hire/train/coach quality assurance team. Quality System and Food Safety System Audits – Conduct cGMPs (Dietary Supplement, Food, Cosmetics, OTC)/GLP/GCP audit and food safety (FSMA, FSVP, IA, HACCP, SQF, GFSI, etc.) audit. Supplier Qualification – Conduct supplier audits, establish processing and product specifications, establish Quality Agreements, and evaluate supplier performance  Private and Public Training – Quality and Food Safety Systems and Regulatory Compliance

Listed skills include Product Development, Gmp, Fda, R&D, and 14 others.