MC Laboratories is continually striving to develop its capabilities so that its clients have access to expert consultation when they need it. In maintaining this commitment, MC Labs is pleased to announce the addition of an ASQ Certified Quality Auditor to its staff of professionals.
Our Auditor has been employed by a major pharmaceutical company in the area of quality for 27 years, with 15 years of focused experience in quality assurance management. She has extensive experience in the oversight and administration of quality systems both in chemistry and microbiology laboratories, as well as manufacturing and production environments. Her experience includes quality assurance and quality systems management, both in-house and out-sourced active pharmaceutical ingredient bulk, oral dosage, aseptic, lyophilization, terminal sterilization and inhalable drug product processes in current Good Manufacturing (cGMP) environments. She has participated in many Food and Drug Administration and European Union regulatory inspections, with responsibility for issuance of observation response and closure reports. She has been a lead auditor conducting both internal and external quality cGMP compliance audits for her prior employer and numerous contract pharmaceutical manufacturers throughout the United States and Puerto Rico. She has a demonstrated ability to lead and manage external audit programs with regard to audit scheduling, preparation, performance and follow-up of findings to closure. She has experience and education in deviation investigation methods and root cause analysis.
Her education includes a Master’s degree in Business Administration, a Bachelor of Science degree in Life Sciences and an Associate of Science degree in Medical Technology from Indiana State University. She is a member of the American Society for Quality and is a Certified Quality Auditor.