The Military HIV Research Program (MHRP) is dedicated to HIV vaccine development, prevention, disease surveillance and care and treatment for HIV.HIV-1 continues to pose a significant and persistent threat to the military and allied forces both in terms of readiness and force protection. The brisk pace of deployments to locations throughout the world requires the MHRP to develop products and capabilities with an international scope.This program builds on the strength of the U.S. military medical research community, and addresses specific HIV research requirements to meet its mission: prevention of HIV-1 disease in the active force and, by extension, the global community at risk of infection.Responsibilities:1. Reviews and approves documents. Develops and maintains a centralized documentation system for all records.2. Ensure internal audits are performed each month and report findings at the monthly QA meeting after passing to the Lab Manager for review. Identifies critical episodes, events deficiencies, recommends remedial actions, confirms implementation of actions and reports findings to laboratory management.3. Track the receiving of Proficiency test panels and submitting of results to vendor (generate a calendar of all PTP´s to be received each year, documenting date received, date results submitted, and score received). The program includes serology/immunology, Western Blot, HTV-1 RNA Viral Load, HIV Genotype, Hematology and Flow Cytometry.4. Coordinates all equipment/building validation issues and ensures regulatory compliance.5. Reviews and tracks all Standard Operating Procedures (SOPs), medical device reports and Occurance Reports. Manages monitoring, evaluation, and corrective actions and reports the results to the appropriate department level committee.6. Oversees the duties of 3 staff members: Document Control; QA Specialist and Technical Writer7. Serves as the advisor and senior consultant to laboratory management and other officials on various aspects of laboratory performance improvement. Performs duties related to medical technology such as instructing and credentialing supervisors in the theoretical and practical aspects or the performance improvement program.8. Manages external proficiency program to ensure that all analyses and procedures surveyed are in accordance with current accrediting and regulatory agency guidelines. Coordinates the ordering of surveys through the College of American Pathology (CAP), Accutest, and VQA. Manages the evaluations of surveys, requesting the investigation of all failed challenges and directing documentation of corrective action.9. Represents HDRL on department level performance improvement and infectious control committees.10. Manages the risk management program maintaining all incident report documentations and coordinating response to the appropriate committee.11. Write SOPs as related to the Quality Management Plan12. Completes other projects as needed.Required Knowledge, Skills, and Abilities:- Mastery of medical technology principles, theories, practices, and methodologies to perform the full range of duties connected with the design and implementation of a clinical QC program. - Comprehensive and detailed knowledge of accrediting and regulatory agency requirements, including federal and state laws. - Knowledge of document control, validation/calibration of system and equipment and audit of records- Excellent organization, computer and communication skills; ability to handle multiple priorities.Minimum Education/Training Requirements: Bachelor´s degree in ScienceMinimum Experience: 4 to 6 years experience in quality assuranceSupervisory Responsibilities/Controls:Supervises Quality Assurance TechniciansWork Environment: Office and laboratory environment