Performance of serological and immunological assays and specimen processing and rejection in accordance with laboratory SOPs; manufacturer guidelines and CAP/ FDA regulations.
Ensures compliance with all QA program requirements and documents activities in accordance with established standards.
Perform high throughput testing for HIV; STI; blood borne infections; and/or transfusion transmissible infection
Perform serological screening; supplemental confirmatory testing; and molecular clinical (viral load) and therapeutic (resistance genotyping) monitoring; molecular diagnosis
Conduct of safety and end point testing for Phase 1 vaccine; therapeutic clinical trials; Phase II clinical trials; molecular monitoring (viral load/genotypic resistance); per CAP/CLIA/CLIP regulatory requirements.
B.S. in medical technology; biological or chemical discipline preferred.
Excellent laboratory and technical skills; ability to work independently; excellent record keeping ability; excellent interpersonal and communication skills.
Documented experience in high throughput automated platform for HIV; STI; BBI; TTI serological screening; supplemental confirmatory testing; and molecular clinical (viral load) and therapeutic (resistance genotyping) monitoring; molecular diagnosis; conduct of safety and end point testing for Phase 1 vaccine; therapeutic clinical trials; Phase II clinical trials; Global Health initiatives inclusive of molecular monitoring (viral load/genotypic resistance); GCP cohort studies; detection and monitoring of pathogens of US Military and US National interest per CAP/CLIA/CLIP regulatory requirements.
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.
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