This position is a member of the KeraLink Quality, Regulatory, & Compliance Team, reports directly to the Director, Quality, Regulatory & Compliance and is responsible for ensuring all compliance functions are completed and compliant with KeraLink procedures, FDA regulations, EBAA Procedure/Medical Standards, and applicable state regulations as defined within the Key Areas of Responsibility.
Key Areas of Responsibility:
Will ensure that assigned Ocular Centers are audit ready at all times by operating in compliance with FDA Regulations, EBAA Procedure/Medical Standards, State Regulations, and KeraLink Policies/Procedures.
Will ensure that all Complaint/Event Handling procedures are well defined & being followed.
Will conduct investigations and initiate all identified Corrective/Preventive Actions (CAPAs) resulting from Non-Conformance and/or Complaint investigations. Will be responsible for contacting the appropriate people to obtain any information needed to aid in the investigation. Will ensure that all required notifications occur within the established regulatory requirements. Will ensure the timely closure of all Complaints/Events.
Will assist in the management of the Internal Audit Program to ensure a Quality Management System compliant with applicable regulatory agencies to include, but not be limited to State, Federal, International, and Industry Standards.
Will be knowledgeable of all of the governmental regulations, accreditation agency requirements and internal Policies/Procedures in order to ensure operational compliance.
Will ensure that all equipment lists are kept current, the equipment binders are consistent across the network, and calibrations are current & complete. Will personally perform the record review and sign-off onsite as needed.
Will ensure that all ocular center quality donor record reviews are completed per procedure and will personally perform the record review and sign-off onsite as needed.
Will ensure that all location laboratory manual reviews are completed per procedure and will personally perform the record review and sign-off onsite as needed.
Will conduct training as required and will ensure all departmental training plans are completed and all training files are current.
Will ensure that all ocular center medical directors, site directors/managers and staff perform the required annual procedure/competency reviews & the reviews are documented.
Will ensure that all required recovery partner staff annual competency reviews are completed and documented.
Will assist with the completion & submission of the EBAA Statistics for all ocular centers within the EBAA defined required timeframes.
Will compile & submit all of the required regulatory licensure documentation as assigned.
Will participate as an audit/inspection liaison as assigned.
Will conduct Internal Audits as assigned.
Will qualify suppliers, conducts supplier audits, and maintain a current master supplier list.
Will be responsible for ocular production and quality documentation review & approval. Will personally define and write key ocular operating procedures and technical documents.
Will develop, implement and monitor key quality metrics and communicate to Management the status & progress of the Quality System.
Will interface on a continual basis concerning Quality System performance & issues with the Director, Quality, Regulatory & Compliance, KeraLink Quality, Regulatory, and Compliance Team, and KeraLink Ocular Center Management and Staff.
Will participate in processing & equipment IQ/OQ/PQ validation requirements from planning, protocol definition, protocol execution, data analysis, report writing & approval, and defining procedures & training requirements. Will ensure that the Validation Master Plans are in effect and current.
Bachelor’s Degree, preferably in a life science; equivalent experience may be accepted.
Must be able to travel 50% - 75%.
Minimum of 3 years of Quality Assurance experience within a FDA regulated industry, i.e., Human Cellular and/or Tissue Processing and/or tissue/eye banking.
Process qualification and validation project leadership skills a plus.
Experience with ensuring quality & regulatory requirements necessary for a new product introduction process.
Experience with Non-conforming Materials/Events & Material Review Boards.
Experience in advanced problem solving including statistical techniques, root cause analysis, and Corrective/Preventive Action Programs to include the verification of effectiveness.
Sound understanding of quality concepts, regulatory compliance requirements and tools including 21CFR1271 (HCT/P), ISO 13485, the FDA QSR, AATB and EBAA guidelines.
Must be computer proficient (Microsoft Office Suite required).
Understanding of human ocular anatomy.
Proven ability to lead and influence in a cross-departmental technical environment.
Internal Number: QRC Coordinator 2018
About KeraLink International
EBAA accredited eye bank. Company details available on the company website.