EDUCATION: Bachelor’s degree in a science related field is required. Appropriate regulatory industry experience or certification may be substituted for education. Thorough knowledge of ocular anatomy and physiology as well as medical knowledge and medical terminology is needed to understand aspects of eye banking.
EXPERIENCE: The Quality Assurance Coordinator should have at least 2 years experience working in a regulated industry. Knowledge and experience with FDA regulations and quality systems (cGTP or cGMP) is a must. The Coordinator should have experience working with quality systems / programs, preferably in eye or tissue banking, medical diagnostics, medical devices or other medical areas. Consideration will be given to candidates with equivalent experience or knowledge from a cross-over profession or industry. An understanding of auditing practices and basic statistical analysis is needed. The Coordinator should be familiar with MS Office, donor databases and electronic quality databases. The position requires excellent people skills, as well as effective written and verbal skills for both internal and external communication. Familiarity with EBAA or AATB medical standards is a plus. Driving may be required, as such a valid drivers license and access to personal vehicle is a requirement for employment.
SUMMARY STATEMENT: The Quality Assurance Coordinator assures compliance with government and industry standards. The Quality Assurance Coordinator monitors SOP/document forms, change control process, champions a continuous quality improvement process, and collaborates with leaders within the organization to ensure compliance with regulatory, accreditation and legislative standards. The Coordinator is responsible for performing administrative aspects that may include interaction with or within the Technical, Quality, Community & Professional Relations and Accounting departments. The Coordinator may be asked to develop and maintain business relationships with surgeons, surgery sites and their staff in an effort to open communication channels for reliable quality monitoring. Training is provided by the managers of each department where applicable.
ASSIGNED RESPONSIBILITIES AND DUTIES:
• Receiving and investigating departures, deviations, and corrective actions
• Reports to regulatory and legislative bodies as needed
• Follow-up and tracking corrective action effectiveness
• As needed, assist with SOP/document change control process
• Assist with records retention control
• Monitor equipment validation, verification, maintenance and certifications
• Perform activities associated with inspections, audits, monitoring, and trending
• Review / audit records and procedures for completeness, accuracy, and compliance
• Activities associated with vendors and contracted service providers - agreements, off site audits
• Assist in supplier qualifications • Perform quality related customer service tasks with current and potential surgeons
• Receive, investigate, and evaluate information to include complaints and new donor information
• Assist in managing adverse reactions/events and complaint trends
• Follow-up and data entry of recipient information for transplanted tissues
• Provide feedback and training to the Technical Manager related to internal audits
• Assess organizational training needs as part of a team; design, coordinate and implement training programs
• Assist in compiling, disseminating, and examining statistical data as directed
Perform other duties as necessary and as assigned by management