Quality Assurance/Quality Control Specialist I or II - 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 I or II 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.

Under the direction of the Quality Assurance Manager, the incumbent is responsible for supporting and ensuring that Quality Assurance and Quality Control practices are met in the College of American Pathologists (CAP) certified HIV Diagnostics and Reference Laboratory (HDRL) and Leishmania Diagnostics Laboratory (LDL); as well as in the Research Assessment and Development Laboratory (RAD) and the Specimen Processing Laboratory and BioRepository (SPL/BioR) within the Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR). The incumbent will assist the Quality Assurance Manager in implementing Good Clinical Laboratory Practice (cGLP) and will work in a team environment to ensure compliance with internal specifications and/or standards as well as all CAP/CLIA/FDA regulatory agency requirements.

NOTE: As a U.S. Government contractor, all HJF employees are required to be fully vaccinated against COVID-19 by December 8, 2021. Proof of vaccination or an approved religious or medical accommodation will be required.

Responsibilities:
  1. Supports the Quality Assurance Manager and Senior QA/QC Specialist to ensure CAP/CLIA/FDA regulatory compliance in all aspects of pre-analytical, analytical, and post-analytical laboratory operations. (20%)
  2. Monitors the laboratory performance and advises the QA Manager and Senior QA/QC Specialist when performance standards are not met. (20%)
  3. Performs quality review of assay runs, maintenance records, training and competency documentation, reagent and equipment verifications, patient records, and other documents as needed. (20%)
  4. Enters Quality Control data for monthly tabulation and review, coordinates with Technical Supervisors to identify trends and outliers. (20%)
  5. Organizes and conducts internal audits of various laboratory sections and documentation. (10%)
  6. Reviews and maintains non-conforming event documentation and logs; ensures appropriate Corrective Actions and Preventive Actions (CAPAs) are implemented, tracked, and trended as appropriate. (10%)

Required Knowledge, Skills and Abilities: Intermediate experience with Microsoft Office. Exposure to laboratory licensing processes and requirements. Ability to identify the Quality System Essentials. Excellent writing skills and attention to detail. Excellent communication skills, conflict management skills, and familiarity with change management principles. Knowledge of CAP, CLIA, and FDA regulatory requirements. Experience working in CAP accredited laboratory. Knowledge of MasterControl, Smartsheet, and/or Q-Pulse and LabWare preferred but not required.

Minimum Education: Quality Control Quality Specialist I: Vocational or technical training degree required for this position. Associates degree preferred.

Quality Control/Quality Specialist II: Associate's degree required for this position. Bachelor's degree in a science related field preferred.

Minimum Experience/ Training Requirements:

QA/QC I: Minimum of 0-2 years of experience required.

QA/QC II: Minimum of 3-5 years of experience required.

Required Licenses, Certification or Registration: ACSP certification or equivalent preferred.

Physical Capabilities: Requires lifting materials up to 20lbs.

Work Environment: Position takes place around conditions that pose risk of exposure to pathogens.

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.

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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