QA/QC Specialist

Join the HJF Team!

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. 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. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals

HJF is seeking a QA/QC Specialist to support the Quality Management System for the Diagnostics and Countermeasures Branch (DCB), within the Center of Infectious Disease Research (CIDR) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring and Rockville, MD. HJF provides scientific, technical, and programmatic support services to DCB.

The incumbent will work with the Quality Assurance Team Lead, Quality Assurance Manager, Laboratory Directors and Department Managers to ensure DCB’s quality systems meet and exceed 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), Clinical Laboratory Improvement Amendments (CLIA), 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.

Responsibilities

• 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.
• Reviews maintenance records, charts/documents, and maintains QA records.
• Conducts internal audits of various Diagnostic, Research and Specimen Processing sections.
• Conducts monthly reviews of Patient Records.
• Reviews, maintains Corrective Action Logs, and ensures corrective actions are completed documented, tracked and trended.
• Conveys QA/QC data and audit findings in a concise and professional manner.
• Writes, reviews SOPs, verification/validation Protocols and Reports.
• Reviews, edits, and version controls all documents using MasterControl (SOPs, Policies, Worksheets, etc.) as they pertain to DCB activities.
• Performs Sub-system Administrator tasks in MasterControl.
• Audits and maintains personnel 6-part training folders and assists with training requirements.
• Maintains Proficiency Testing (PT) records, receipt of PTs, tracking PT assignments, pre-submission review, and review of the post evaluation reports.
• Works with QA Manager/Team Lead to maintain the laboratory websites.
• 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.
• Basic computer skills are required for effective job performance.
• Knowledge of Macintosh and PC related Software, to include Microsoft Office 365 and auditing software applications is a plus.

Qualifications

Education and Experience

• High school diploma, GED, vocational, technical training or degree, Associate's degree, Bachelor's degree preferred.
• 0-2 years of relevant work-related experience.

Work Environment: Office environment.

Work Arrangement: This position is 100% on site and has no teleworking capability.

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

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.

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, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.  Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. 

 Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.