QA/QC Specialist

Updated: August 7, 2018
Job ID: 214013
Status: Full-Time
Regular/Temporary: Regular
Location: Silver Spring, MD, United States

Join the HJF Team!

HJF is seeking a QA/QC Specialist to support the Military HIV Research Program (MHRP) located at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. HJF provides scientific, technical and programmatic support services to MHRP.

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 Laboratory Monitoring (DLDM), U.S. Military HIV Research Program, Walter Reed Army Institute of Research. The incumbent will also work with Laboratory Directors and Managers to implement Good Clinical Laboratory Practices across DLDM’s Technology Assessment Laboratory and their Specimen Processing Laboratory and BioRepository.  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.
  2. Monitors, tracks pre-analytical, analytical, and post analytical performance and advises QA Manager/Team Lead when performance standards are not met.
  3. Reviews maintenance records, charts/documents, maintain QA records.
  4. Conducts internal audits of various Diagnostic, Research and Specimen Processing sections.
  5. Conducts monthly reviews of Patient Records.
  6. Reviews, maintains Corrective Action Logs, and ensures corrective actions are completed documented, tracked and trended.
  7. Conveys QA/QC data and audit findings in a concise and professional manner.
  8. Writes, reviews SOPs, verification/validation Protocols and Reports.
  9. Reviews, edits, and version control all documents using MasterControl (SOPs, Policies, Worksheets, etc.) as they pertain to DLDM activities.
  10. Performs Sub-system Administrator tasks in MasterControl.
  11. Maintains personnel 6-part training folders and assists with training requirements.
  12. Maintains Proficiency Testing records, receipt of PTs, tracking PT assignments, pre- submission review, and review of the post evaluation Reports.
  13. Works with QA Manager/Team Lead to maintain the laboratory website.
  14. Other duties as assigned.

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 Requirements: BS in science field or Medical Technology

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

Minimum Experience: 2-3 years of experience working in the QA field.  Good computer skills are required for effective job performance. Knowledge of Macintosh and PC related Software, Microsoft Excel, FileMaker Pro, MasterControl, Q-pulse or LabWare a plus.

Physical Capabilities: Job performance requires ability to sit for lengthy periods to include, but not limited to data entry at a computer terminal.

Supervisory Controls: The incumbent will report directly to the DLDM QA Team Lead.

Work Environment: 503 Robert Grant Avenue, building 503 and 9100 Brookville Road, building 508, Silver Spring, MD Laboratories, and 13 Taft Court, Rockville MD, the Specimen Processing Laboratory and Biorepository. The incumbent will work in laboratory environments that handle bio-hazardous materials, and infectious human specimens to include, but not limited to, HIV, Hepatitis B, Hepatitis C, Herpes, HTLV, and syphilis infected material. This laboratory supports work of investigators of diverse scientific disciplines and nationalities and 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.

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