JOB CLASSIFICATION: Full time, non-exempt COMPENSATION: Starting Annual Salary $66,600-72,000 plus benefits
EDUCATION: Although not required, a Bachelor’s Degree in science, management or business is recommended, commensurate experience may substitute for a degree. Thorough knowledge of ocular anatomy and physiology as well as medical knowledge/terminology is needed to understand aspects of eye banking. Excellent reading and writing skills and written communication is required. EXPERIENCE: 5 years of firsthand regulatory/quality experience in an FDA regulated industry is required in the absence of previous eye banking experience. Experience in the eye banking industry is desirable and may substitute for or reduce the 5-year requirement in quality/regulatory for an individual that otherwise meets all other requirements. Previous experience in a position that required collaborative cross department interactions with constructive, positive, and professional outcomes is required. Pervious auditing experience is also a requirement.
SUMMARY STATEMENT: Must comply and ensure adherence with FDA, cGTP, EU, EBAA, OSHA, Rocky Mountain Lions Eye Bank (RMLEB) SOPs, and all other applicable regulatory requirements. Ensure that the Quality requirements and organizational goals are effective and in compliance. Provide expertise and guidance regarding domestic and international regulatory and quality requirements needed to meet complaints, adverse reactions/events, regulatory reporting, internal and external auditing, document preparation, performance metrics and review of controlled documents. This position may also provide guidance to RMLEB customers and RMLEB personnel. The QA Manager is responsible for regulatory reporting, fillings and registrations related to transplant and product development.
ASSIGNED RESPONSIBILITIES AND DUTIES:
Develop, implement, and maintain procedures in support of regulatory compliance
Work with Technical Department to write, implement, and review technical SOPs to promote safety to staff and tissue recipients consistent with all applicable regulatory agencies (EBAA, FDA, OSHA, EU)
Responsible for maintaining donor, tissue, recipient, training, facility and other critical or regulated eye bank records to include all aspects of document control and revision process.
Host external audits (plan, document, and act as primary contact) and respond to audit findings.
Oversee internal audit system (Schedule, create checklist, communication, opening meetings, conduct audits, closing meetings, creating audit report, maintain external/internal audit files and records and oversee corrective actions)
Oversee Complaint Handling, Adverse Reaction/Event Reporting, Deviation Reporting, Recall, and Regulatory License/Registration systems
Develop/provide reports for applicable quality metrics and trending.
Oversee regulatory audits & responses in cooperation with other departments.
As needed helps to maintain ongoing facility and equipment maintenance, qualification, and certifications.
As needed helps to execute equipment qualifications and/or process validations.
Oversees physical and facility related aspects of OSHA compliance, record keeping and training (safety officer).
Supervises the Quality Assurance Coordinator
Perform other duties as necessary and as assigned by the Executive Director
MISCELLANEOUS POSITION REQUIREMENTS: This job requires driving to perform position duties. As such, a valid driver’s license, current automobile insurance and access to a personal vehicle are required. On-call time may be required.