Quality Professional with extensive operational and audit experience in the cGMP manufacturing and laboratory environment. Point-of-contact for FDA Inspectors in nine (9) PAI, GMP, and 510k Inspections. Quality Lead for ISO/CE Auditors in seven (7) Certification and Facility Audits. Team Player known for a positive attitude, clear communication, strong people skills and solid problem-solving abilities. Expertise in the writing, review, and approval of product investigations; CAPA; validation & stability protocols; regulatory submissions; batch records; internal and external audits; GMP training; customer complaints; operating procedures; sample/inspection plans; and QC laboratory documents.