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Raleigh-Durham, North Carolina Area United States

Lead Auditor CQA-ASQ

Medical / Health Care / Pharmaceuticals

Professional individual with over 12 years in the pharmaceutical industry, 10 of those years in Quality Assurance and Regulatory Compliance. Experience in solid dose, over the counter products, pharma products, vaccines and sterile injectables. Held different roles in Quality Assurance including authoring APQRs, reviewing and releasing lots, QA on the Shop Floor Program, Compliance walkthroughs, Shutdowns, review of Clinical Trial Material, Demo and Engineering batches. Within Regulatory Compliance I have performed internal audits and currently manage all Regulatory Commitments for site with almost 3,000 employees. Author bi-monthly reports to Regulatory agencies like FDA, TGA and Hea...