Quality Assurance/Quality Control Specialist - Diagnostics and Countermeasures Branch - Military Veterans

at Henry M. Jackson Foundation

Silver Spring, Maryland

Join the HJF Team !

HJF is seeking a Quality Assurance/Quality Control Specialist to support the Diagnostics and Countermeasures Branch (DCB) located at 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 supporting and ensuring the Quality Assurance and Quality Control practices are met in the College of American Pathologists (CAP) certified HIV Diagnostics and Reference Laboratory (HDRL), and the Leishmania Diagnostics Laboratory (LDL), within the Department of Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research, Walter Reed Army Institute of Research. The incumbent will also work with Laboratory Directors and Managers to implement Good Clinical Laboratory Practices across DCB's Technology Assessment Laboratory (TAL) and Specimen Processing Laboratory and BioRepository (SPL/BioR). The incumbent will work in a team environment to assure compliance with internal specifications and/or Standards as well as all CAP/CLIA/FDA regulatory agency requirements.

Responsibilities:
  1. Supports Quality Assurance Manager/Team Lead to ensure CAP/CLIA/FDA regulatory compliance in all aspects of laboratory operations. Monitors, tracks pre-analytical, analytical, and post analytical performance and advises QA Manager/Team Lead when performance standards are not met. (20%)
  2. Reviews maintenance records, charts/documents, maintain QA records. Reviews, maintains Corrective Action Logs, and ensures corrective actions are completed documented, tracked and trended. (20%)
  3. Conducts internal audits of various Diagnostic, Research and Specimen Processing sections. Conducts monthly reviews of Patient Records. Conveys QA/QC data and audit findings in a concise and professional manner. Audits and maintains personnel 6-part training folders and assists with training requirements. (20%)
  4. Writes, reviews SOPs, verification/validation Protocols and Reports. Reviews, edits, and version control all documents using MasterControl (SOPs, Policies, Worksheets, etc.) as they pertain to DCB activities. Performs Sub-system Administrator tasks in Master Control. (20%)
  5. Maintains Proficiency Testing records, receipt of PTs, tracking PT assignments, pre- submission review, and review of the post evaluation reports. (10%)
  6. Works with QA Manager/Team Lead to maintain the laboratory website. (10%)
  7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities: Excellent laboratory, technical, communication and interpersonal skills. Ability to work independently once trained and maintains excellent records with a keen attention to detail. Knowledge of GMP, GCP, GCLP and or CAP/CLIA/FDA regulatory requirements and experience working in a GCLP, GMP, CAP/CLIA and/or FDA accredited laboratory. Excellent record keeping and organizational skills.

Minimum Education: Associate degree is required. Bachelor's degree in science field or medical technology is preferred.

Minimum Experience/ Training Requirements: 3-5 years of relevant work experience is required.

Required Licenses, Certification or Registration: Certification as Medical Technologist, ASCP or equivalent certification is preferred.

Background/Security: Must have lived in the U.S. 3 out of the past 5 years; eligible to obtain and maintain a Tier I investigation/ Public Trust and a Common Access Card (CAC).

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.

Silver Spring, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

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