Gregory Auld Email & Phone Number

■ Assist or lead in the preparation, handling, and response for external audits/ inspections by the US FDA, Health Canada, other international regulatory bodies, and wholesale customers.■ Oversee team of QA & QC inspectors in manufacturing warehouse environment.■ Create, execute, and approve internal studies for equipment installation & operational qualifications, process & performance qualifications, product stability studies, cleaning validations, test method validations, design qualifications, and freeze/ thaw/ heat impact studies■ Generate, review, and approve the creation & revision of SOP’s, master batch records, quality investigation reports, material specifications, technical files, safety data sheets (SDS’s) for OTC drug products and medical devices, annual product reviews, post-market surveillance reports, and management review presentations.■ Implement and manage statistical tacking, evaluation, and response for a wide variety of manufacturing and quality system metrics. ■ Produce monthly sales by items summaries and complaint trend analysis reports according to product/ component types.■ Perform internal gap analysis and quality process improvement evaluations for procedures related to manufacturing, document/record control, complaint handling, inventory control, training compliance, and material shipping/ receiving.■ Inspect, investigate, and report on suspected deviations and non-conforming materials including root cause analyses, risk analysis, proposed action plans, effectiveness verification■ Aid in R&D for OTC drugs and medical devices related to product formulation, manufacturing processes, device functionality, and the determination of finished product specifications.■ Go-to QA liaison for Customer Service, Sales, and R&D departments.

Bachelor'S Degree, Biology/Biological Sciences, General

Education record

Education record