Position Summary
AAS is seeking a researcher/ scientist with expertise in laboratory quality assurance to develop and implement a Laboratory Quality System. The candidate will strengthen the ID laboratory quality system compliance to insure that the vaccine reference viruses, serologic diagnostics and viral diagnostic materials provided for pandemic vaccine development meet the highest possible quality standards. The candidate will provide quality assurance services to comply with Good Laboratory Practices (21 CFR Part 58) for vaccine and diagnostic reagents produced at CDC as outlined by FDA. Information obtained from these efforts will be used in strategic decision making, control and prevention program planning and program effectiveness evaluation prior to, during and after influenza outbreaks, epidemics or pandemics. The selected candidate will work in the Atlanta Metropolitan Area at the CDC Roybal Campus. Salary will be determined based on education and experience. A full benefit package will be provided. Relocation support will not be provided. The selected candidate will have to obtain and maintain a CDC security clearance.
Position Responsibilities
Specific task include:
Develop and implement a Laboratory Quality System for influenza vaccines and reagents for diagnostics development
Review previous audits of CDC influenza laboratory and data management quality systems
Inventory all study specific procedures (SSP) and standard operation procedures (SOP) and provide ongoing oversight and approval of procedures.
Conduct laboratory data and computer systems audits
Audit reporting system for test failure, noncompliance and other deviations
Develop a SOP describing systems validation procedures
Develop procedures for document and version control of software and hardware
Conduct training on documentation and competency training based on SSP and SOPs
Conduct periodic good laboratory practice (GLP) training for program staff
Assist in development of assay and method validation procedure for CLIA testing
Develop and implement equipment qualification/validation procedures to include equipment calibration plans.
Review and Apply
It is NOT ok to contact this poster with commercial interests.
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