As the Senior Clinical Laboratory Specialist for Regulatory Affairs, you will provide leadership and technical expertise for the quality and compliance program within the Department of Pathology and Laboratory Medicine, primarily for Transfusion Medicine, focusing on Blood Donation and Component Manufacturing. Success in this vital role will require in-depth knowledge of the relevant regulatory and accrediting agency requirements for blood banks, including CLIA, Department of Public Health, FDA, CAP and AABB. You will maintain quality systems throughout our multidisciplinary laboratory environment while ensuring adherence to all regulations, laws, guidelines, and standards of the licensing, accrediting, government and credentialing agencies. You will also:

•Review quality data, proficiency testing activities and validation plans
•Perform assessments/audits
•Develop new policies, processes and procedures
•Provide technical review for both the laboratory and UCLA Health
•Review nonconforming events to identify systematic problems
•Review data trends for risk management/process improvement
•Oversee document control and record retention practices and conduct trainings

Salary Range: $57.22 - $73.68/hour