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Quality Assurance Specialist
| Hours | Full-time, Part-time |
|---|---|
| Location | Atlanta, GA ATLANTA, Georgia |
About this job
Headway Workforce Solutions is currently seeking a Quality Assurance Specialist for an 6 month opportunity in Atlanta, GA with our partner, the world’s largest nonprofit research and development organization.
The Technical On-Site Professional Services is working with HHS/CDC in supporting efforts for pandemic influenza preparedness. The CDC ID provides critical standards for pandemic preparedness to the U.S. State Public Health Laboratories and acts as a World Health Organization (WHO) reference laboratory supporting international influenza surveillance and response networks. Rapid genetic and antigenic characterization of circulating viral strains coupled with vaccine development are essential components to increase pandemic readiness and response. TOPS is supporting CDC in research and development efforts to eliminate data gaps in influenza surveillance by increasing the diagnostic and immunization tools available to clinical providers, public health laboratories and domestic and international partners. Relocation support is not available for this position.
RESPONSIBILITIES:
- Assist the Quality Assurance Manager with the implementation and continuous improvement of a Laboratory Quality System for the Influenza Division of CDC
- Assist with document control and training related to CLIA, GLP, and GMP
- Prepare, review and/or approve procedures
- Conduct internal audits of laboratories, laboratory data, and computer systems
- Assist with equipment qualification/validation procedures to include equipment calibration and preventive maintenance
- Communicate progress orally and in writing (monthly) with technical monitor and others.
- Coordinate new staff quality orientation and training as well as ongoing quality training as needed
JOB REQUIREMENTS:
- BS Degree in biology, microbiology, virology, biochemistry or other life science
- Have at least 5 years quality assurance experience in microbiology/diagnostic CLIA certified laboratories, IVD manufacturing, medical device manufacturing, or pharmaceutical industry
- Demonstrated interpersonal and management skills with ability to work collaboratively with other scientists and laboratorians
- Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) or equivalent
THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:
- Quality assurance system development expertise with a strong background in the FDA regulatory environment for medical devices or pharmaceuticals or CLIA laboratory environment
- Prior bench experience working in a CLIA, GLP or cGMP environment
- • Experience hosting audits by FDA
Headway Workforce Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Headway Workforce Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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