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The incumbent will be responsible for the management, coordination, and implementation of the Quality Management Program (QMP) for the Department of Laboratory Diagnostics and Monitoring (DLDM), within the U.S. Military HIV Research Program (MHRP), at the Walter Reed Army Institute of Research (WRAIR). DLDM encompasses two College of American Pathologists accredited laboratories, the HIV Diagnostics and Reference Laboratory (HDRL) and the Leishmania Diagnostics Laboratory (LDL), and three clinical research laboratories: the Technology Assessment Laboratory (TAL); the Clinical Evaluation Unit; and the Specimen Processing Laboratory and BioRepository (SPL/BioR). The incumbent will be responsible for ensuring DLDM laboratories are maintained at the highest U.S regulatory agency and accrediting body standards to include the College of American Pathologists (CAP), Department of Defense (DOD) Clinical Laboratory Improvement Program (CLIP), Good Clinical Laboratory Practices (GCLP) for conduct of clinical trial research, and U.S. FDA requirements for conduct of testing and management of documentation supporting U.S. FDA regulated Pre-Market Application and 510K clinical trials.
- The incumbent will report to the Director of Operations, DLDM.
- The incumbent will work directly with the DLDM Director of Operations, Laboratory Directors, Associate Laboratory Director, and Section Chiefs to manage, implement, and monitor Quality System Essentials (QSEs) and maintain adherence to all U.S. regulatory agency and accrediting body requirements; serves as regulatory agency specialist.
- Coordinates activities with U.S. agencies and accrediting bodies for on-site inspections/audits, organizes and coordinates required internal/interim self-assessments, and collates post-inspection reports and responses, if required.
- Maintains certificates for all U.S. agencies.
- Interprets and monitors regulations/standards governing all DLDM laboratory sections and evaluates written policies and procedures for compliance.
- Mentors, trains, and manages a team of Quality Specialists.
- Summarizes quality control/quality assurance, and quality improvement meeting activities. Tracks and ensures completion of all action items in coordination with DLDM Senior Leadership.
- In conjunction with DLDM leadership identifies, implements, and trends key indicators for regulatory agency compliance.
- Manages, tracks, and trends Occurrence Reports; prepares, in conjunction with Laboratory Manager/DLDM Leadership Corrective and Preventive Action Plans, and conducts investigations/audits as required.
- Performs internal audits, including mock audits, and external site and system audits/assessments to monitor quality program compliance to written policies, procedures, and regulations; prepares formal audit reports.
- Leads efforts for Quality Improvement.
- Ensures that all Standard Operating Procedures (SOP’s) are prepared according to the manufacturer’s package inserts, operational manuals, and are compliant with all the relevant regulations.
- Manages and ensures update of DLDM website, organizational chart, and the laboratory policies in a timely manner.
- Monitors risk management activities of DLDM and provides recommendations for improvement to the Director of Operations.
- Manages Quality Control (QC) Program to ensure all assay results are acceptable and valid.
- Manages Proficiency Test (PT) Program; oversees selection and purchase of appropriate proficiency testing materials; ensures all results are reviewed and reported in accordance with PT event requirements; tracks and documents results; and, if required, ensures that appropriate corrective action/preventative actions are implemented for discrepant results.
- Collaborates with DLDM leadership to develop, implement and monitor changes to policies, procedures, and programs to meet DLDM client needs.
- Conducts a bi-annual customer service survey; compiles results for review by DLDM Leadership.
- Prepares annual Quality Assurance Report and submits results for review by DLDM Leadership.
- Reports all facility, personnel, and safety issues to the Laboratory Director.
- Performs all other duties as assigned by the Laboratory Director.
- Laboratory Quality Program Management or equivalent experience.
- Experience in implementing CAP/CLIA requirements, conducting reviews, and monitoring implementation of and compliance with U.S. regulatory agency requirements.
- Knowledge of Good Clinical Laboratory Practice guidelines and the Department of Defense Clinical Laboratory Improvement Program requirements, a plus.
- Experience in Proficiency Test Programs, Occurrence Management, Corrective Action/Preventive Action Management, and Training programs (including tracking and trending).
- Experience hosting U.S regulatory agencies during announced or unannounced inspections/audits.
- Excellent interpersonal, organizational, management, and communication skills.
- Experience working with document and quality management software such as Master Control and Q-pulse.
Minimum Education/Training Requirements: BS in Medical Technology or related field.
Minimum Experience: 3-5 years experience working in a regulated laboratory environment. At least 3 years of Supervisory and/or management experience preferred. Must have served as a technical staff member or as Clinical Laboratory Supervisor.
Required Licenses, Certification or Registration: Certification as Medical Technologist, ASCP or equivalent certification is preferred.
Supervisory Responsibilities/Controls: The incumbent will oversee four Quality Assurance Specialists.
Work Environment: The Henry M. Jackson Foundation (HJF) at 9100 Brookville Road, BLDG 508, Silver Spring MD Laboratories; DLB 503 Robert Grant Avenue, Silver Spring, MD; and 13 Taft Court, Rockville, MD. The incumbent will not directly handle bio-hazardous materials, but work in laboratories that test infectious human specimens which may contain, but not limited to, the following pathogens: HIV, Hepatitis B, Hepatitis C, Herpes, HTLV, and syphilis infected material. DLDM laboratories support work of investigators of diverse scientific disciplines and nationalities; position requires good interpersonal skills for effective job performance.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.