Lydia Shaffer

Lydia is responsible for monitoring the Immunologix Laboratories quality management system. Her role includes auditing and monitoring of bioanalytical studies and supportive operations for conformance with applicable regulatory requirements, protocols and study plans, SOPs, test methods, etc. as well as acting as the point person for the sponsor and agency inspections. She assures management that the facilities, equipment, personnel, methods, practices, records and controls for bioanalytical laboratory studies at Immunologix Laboratories are in conformance with applicable GLP and GCP regulations and guidelines. Lydia is a certified Registered Quality Assurance Professional (RQAP-GLP and RQAP-GCP) and holds ASQ certifications as a Certified Quality Auditor (CQA) and Manager of Quality/Organizational Excellence (CMQ/OE). She is a member of the society of Quality Assurance, The American Society for Quality, and the Research Quality Association. Lydia has over 20 years of industry and CRO experience.