Position is responsible for ensuring overall compliance of the Kentucky Lions Eye Bank with applicable standards and regulations. Essential duties include: *Develop, implement, monitor and archive policies and procedures pertaining to quality control and improvement. *Ensure policies, procedures and quality manual maintains compliance with EBAA medical standards, state/federal laws and regulations and reflects current practice. *Facilitate inspections by accrediting and regulatory agencies. *Perform internal and external audits. *Ensure appropriate validations, calibrations and certifications are performed and at a frequency that meets or exceeds applicable standards. *Assist in the process of obtaining and renewing tissue bank licenses and required updates to eye bank's facilities FDA tissue bank establishment registrations. *Assist with development of validation plans, validation of all new procedures, and perform immediate follow up upon implementation.
At least 2 years of quality experience. At least 1 year of eye, organ, tissue or blood banking experience. Working knowledge of Microsoft Excel and Word. Meticulous.