This position performs professional clinical laboratory science work for a military medical treatment facility (MTF); developing, implementing, and overseeing policy related to health quality and safety standards for laboratories under governing Federal statutes. Major Duties 1. Quality Assurance and Quality Control Program Execution: Serves as the Quality Assurance (QA) Clinical Lab Scientist for the Blood Donor Center. Responsible for the independent development, execution, and maintenance of quality assurance and quality control systems governing donor eligibility determination, blood collection, testing, component preparation, storage, labeling, distribution, and transfusion support. Ensures that laboratory and donor center processes comply with Food and Drug Administration (FDA) regulations, Department of War (DoW) and command policy, Association for the Advancement of Blood and Biotherapies (AABB), College of American Pathologists (CAP), Collaborative Learning in Practice (CLIP), Joint Commission, and other applicable regulatory and accrediting agency requirements. Functions in an independent technical and advisory role, without program ownership or final regulatory authority. Plans, develops, implements, and maintains a comprehensive QA/QC program for blood donor center operations. Designs quality control procedures for new and existing tests, equipment and processes, identifying appropriate control materials, acceptable performance ranges, statistical parameters, and surveillance methods to monitor within-run, between-run, and long-term trends. Evaluates QC data to detect shifts, trends, or failures; assesses impact on donor safety and product quality; and initiates corrective and preventive actions in accordance with regulatory and accrediting requirements. Ensures QC systems effectively monitor essay performance, equipment reliability, reagent integrity, and process consistency. 2. Validation, Proficiency Testing, and Surveillance: Validates test systems, equipment, and processes to ensure they consistently produce accurate and reliable results meeting predetermined specifications. Coordinates and evaluates participation in external proficiency testing programs reliant to donor testing and transfusion services. Investigates unsatisfactory proficiency testing results, documents findings, and implements corrective actions. Maintains surveillance systems to monitor variables affecting the quality and reliability of laboratory and donor testing services. 3. Audits, Assessments, and Corrective Actions: Conducts internal audits and quality reviews of donor center operations, records, and procedures. Identifies deficiencies, non-conformances, and adverse events. Performs root cause analysis and develops, implements, and monitors corrective and preventive action (CAPA) plans. Prepares audit reports and QA documentation detailing findings, analyses, and recommended actions and reports progress to laboratory management. 4. Documentation, Recordkeeping, and Information Systems: Establishes, maintains, and evaluates QA-related recordkeeping systems to ensure data integrity, traceability, and regulatory compliance, including both manual and computerized laboratory information systems. Ensures accurate accession, documentation, reporting, and retention of donor and blood product records. Maintains QA documentation, SOP indexes, validation records, audit files, and proficiency testing records. 5. Regulatory Support, Consultation, and Training: Serves as the primary QA technical liaison during regulatory inspections and audits. Provides documentation, explains QA/QC processes, and prepares draft responses to inspection findings in coordination with laboratory leadership. Provides technical consultation, guidance, and training to medical technologists, technicians, nurses, physicians, and other staff on QA principles, regulatory requirements, and best practices in blood donor operations. Instructs trainees and staff in the theoretical and practical aspects of quality assurance, donor testing, and transfusion safety. Represents the Blood Donor Center on quality management, utilization review, and performance improvement committees, advising leadership on QA findings, trends, and compliance risks. Performs other duties as assigned.