The Henry M. Jackson Foundation for the...
Quality Assurance Supervisor
The Henry M. Jackson Foundation for the..., San Diego, California, United States, 92189
Join the HJF Team!
HJF is seeking a
Quality Assurance Supervisor
who 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 ongoing, 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. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators 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.
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 them to the 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.
Supervisory Responsibilities:
Direct Supervisor : Direct authority to make decisions on employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and direct 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, and 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 required.
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. 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.
Employment with HJF is contingent upon successful completion of a background check, which may include contacting professional references, verification of previous employment, education and credentials, and a criminal background check.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
#J-18808-Ljbffr
HJF is seeking a
Quality Assurance Supervisor
who 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 ongoing, 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. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators 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.
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 them to the 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.
Supervisory Responsibilities:
Direct Supervisor : Direct authority to make decisions on employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and direct 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, and 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 required.
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. 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.
Employment with HJF is contingent upon successful completion of a background check, which may include contacting professional references, verification of previous employment, education and credentials, and a criminal background check.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
#J-18808-Ljbffr