Team Lead, Quality Assurance – Diagnostics and Countermeasures Branch
Henry Jackson Foundation for the Advancement of Military Medicine
Location: Silver Spring, Maryland
Type: Full Time
Internal Number: TEAML002904
Join the HJF Team!
HJF is seeking a Team Lead, Quality Assurance to support the Diagnostics and Countermeasures Branch (DCB) located at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. HJF provides scientific, technical, and programmatic support services to DCB.
The incumbent is responsible for leading a Team of Quality Assurance (QA) and Quality Control (QC) professionals in the implementation and monitoring of QA/QC best practices and ensuring all staff and procedures meet regulatory requirements within the Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR) at the Walter Reed Army Institute of Research (WRAIR). The incumbent will work within DCB’s College of American Pathologists (CAP) accredited laboratories, the HIV Diagnostics and Reference Laboratory (HDRL) and Leishmania Diagnostics Laboratory (LDL), as well as our Research, Assessment, and Development (RAD) Laboratory, and Specimen Processing Laboratory/Biorepository (SPL/BioR). The incumbent will assist the QA Manager in improving DCB’s quality management plan and streamlining the QA Group’s activities, as well as implementing Good Clinical Laboratory Practice (GCLP) to provide support to laboratory staff and processes, ensuring compliance with internal specifications and/or standards and guidelines to meet all CAP, Clinical Laboratory Improvement Amendments (CLIA), and U.S. Food and Drug Administration (FDA) requirements as applicable. The incumbent will report directly to the Quallity Assurance Manager for DCB.
NOTE: As per Executive Order 14042, all HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
Provides oversight and support to QA/QC team; ensures compliance with CAP, CLIA, and FDA regulatory requirements, as appropriate, for all aspects of laboratory operations. (25%)
Mentors, trains, and leads QA/QC Specialists; understands, organizes, and schedules daily, monthly, and annual tasks. (25%)
Leads in the implementation and monitoring of process improvements related to the Quality System Essentials. (20%)
Chairs monthly QA meetings and provides critical updates to Senior Management. (10%)
Completes regulatory package documentation for licensure, accreditation, etc. (i.e., CAP Accreditation, Self-Inspection). (10%)
Prepares for and leads external audits, implements corrective actions/preventive actions (CAPAs) as appropriate, conducts pre- and post-inspection meetings. (10%)
Required Knowledge, Skills and Abilities: Experience working in a CAP accredited laboratory and/or clinical diagnostic environment, preferably in a Quality related role. Understanding of applicability of CAP/CLIA requirements from laboratory and quality standpoint. Knowledge and experience with implementing and maintaining processes that involve Proficiency Testing, Training and Competency, Non-Conforming Events/Occurrence Management, and CAPA tracking and trending. Understanding of Equipment Verification, Laboratory Developed Test (LDT) Validation, and Assay Verification. Excellent interpersonal, management, organizational, and communication skills. Experience working with MasterControl is preferred and with Q-Pulse a plus.
Organizes and leads internal audits of various laboratory sections and documentation.
Monitors and tracks pre-analytical, analytical, and post analytical performance; advises QA Manager when performance standards are not met.
Performs quality review of Verification and Validation Plans, Summaries, and/or Reports.
Reviews and maintains non-conforming event documentation and logs; ensures appropriate CAPAs are implemented, tracked, and trended as appropriate.
Reviews monthly Quality Control data, coordinates with Technical Supervisors to identify trends and outliers.
Oversees Proficiency Testing (PT) receipt, tracking, submission, evaluation, and documentation.
Performs quality review of assay runs, maintenance records, training and competency documentation, new reagent lot and post-maintenance verifications, patient records, and other documents as needed.
Uses MasterControl to collaborate on new and revised SOPs, policies, worksheets, etc.; approves documents for publishing, and performs minimal Sub-System Administrator tasks.
Approves timesheets and manages other personnel functions, as appropriate, for QA/QC Specialists.
Completes annual performance reviews for QA/QC Specialists with QA Manager advisement.
Minimum Education: Bachelor’s degree in a science related field.
Minimum Experience/ Training Requirements: Minimum 6-8 years of experience required.
Required Licenses, Certification or Registration:Certification as a Medical Technologist, ASCP or equivalent is preferred.
Supervisory Responsibilities: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.
Work Environment: This job takes place in an office and laboratory environment.
Work Arrangement: 100% on-site.
Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
About Henry Jackson Foundation for the Advancement of Military Medicine
Are You Ready to Make a Difference in Military Medicine?
For more than 35 years, HJF has been committed to a singular mission: advancing military medicine. When you join our team, you will join one of the 30+ research programs or centers that include advanced surgery, precision medicine, genomics, cancer, infectious disease, chemical, radiological and biological defense, combat injury, and the recovery of the remains of missing service members.
Our vast experience enables us to create innovative, sustainable research solutions that are purpose-built for the needs of our DoD partners.
When you join HJF, you will become part of a focused, inclusive team dedicated to advancing military medicine around the globe.