QUALITY ASSURANCE SUPERVISOR

Overview : Join the HJF Team!

Join the HJF Team!

HJF is seeking an Quality Assurance Supervisor oversees a team of Quality Assurance (QA) and Quality Control (QC) specialists.

This is the first of two managerial levels within the Quality Assurance series.

This position will be in support of Naval Health Research Center (NHRC), Operational Infectious Diseases (OID). OID conducts on-going, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses.

Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations).

In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted.

Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators and, when applicable, county health units in order to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health.

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.

Responsibilities :

• Assigns and provides oversight of all QA and QA / QC specialists daily activities. Monitors the quality of their work.
• Monitors, tracks pre-analytical, analytical, and post analytical performance and advises site leadership when performance standards are not met.
• Prepares monthly reports / graphs and provides to Director, Operations and site leadership for review.
• Manages the Occurrence Reports, Corrective Action Logs, and ensures corrective actions are completed and documented in a timely manner.
• Writes and reviews SOPs, verification or validation Protocols and Reports.
• Manages the Proficiency Testing (PT) records, receipt of PTs, tracking PT assignments, and performs the pre-submission review and the post evaluation reports.
• Prepares documentation for all agency and sponsor audits
• 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.

Supervisory Responsibilities

Direct Supervisor : Direct authority to make decisions on the following : employee hiring, disciplinary action, starting salaries and merit increases;

conduct employee performance evaluations and directs work activities.

Qualifications :

Education and Experience

• Bachelor's Degree in scientific, Medical Technology, or related field required.
• Master's degree preferred.
• Minimum of 6-8 years experience as quality assurance auditor / technician in biological sciences or pharmaceutical science.

Preferably with clinical laboratory experience.

Required Knowledge, Skills and Abilities

• Knowledge of CAP, CLIA and FDA regulatory requirements and experience working in CAP, CLIA and / or FDA accredited laboratory
• Good computer and interpersonal skills
• Attention to detail is required for effective job performance
• Knowledge of Macintosh and PC related software, Microsoft Excel, FileMaker Pro. Knowledge of Master Control or other document control / quality management software.
• US Citizenship and the ability to obtain and maintain a T3 / Secret Clearance

Licenses and Certifications

Certification as Medical Technologist, ASCP or equivalent certified.

Work Environment

This position will take place primarily in an office setting.

Compensation

The likely salary range for this position is $88,600 - $150,800 annually. This is not, however, a guarantee of compensation or salary.

Final salary will be determined based on market analysis, experience, and education.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may 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 contractors 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.