Avomeen Analytical Services, an Ann Arbor-based company that offers product research and development services, has named Carla Totton as the new leader of its quality assurance unit.
In her new position, Totton is responsible for maintaining Avomeen’s compliance with regulatory requirements and standard operating procedures. She will develop, coordinate, implement, and monitor the quality management system for all of Avomeen’s Drug Enforcement Administration, Food and Drug Administration, and ISO 17025 compliant operations and facility.
She will also interface with regulatory authorities; conduct audits of the laboratory, manufacturing operations, work processes, and quality records; and manage accreditation applications and renewals.
Totton will manage the controlled substance program, oversee the metrology and preventative maintenance program to ensure instruments and equipment are functioning properly, and monitor trends to improve areas of the quality system.
“Carla brings a wealth of quality and regulatory expertise to Avomeen, having worked for contract labs in the analytical, development, and manufacturing space,” says Mark Harvill, CEO of Avomeen. “Her blend of experience will further ensure we maintain a quality system and a culture of compliance consistent with global regulatory requirements.”
Totton has more than 10 years of experience in the pharmaceutical industry and was most recently product quality release specialist after being senior regulatory compliance specialist at Catalent Pharma Solutions. She was also a quality auditor and oversaw quality control. She also served as a quality assurance supervisor for ABC Laboratories.
Totton is a certified quality auditor by the American Society for Quality. She holds a bachelor’s degree in business from Columbia College in Missouri.