Job Requisition:Biological Scientist-Quality Assurance Specialist
The CDC is the US Government’s lead for monitoring and responding to seasonal, novel, and pandemic influenza. The mission of the Influenza Division of the National Center for Immunization and Respiratory Diseases (NCIRD), Office of Infectious Disease (OID) at the CDC is to improve global control and prevention of seasonal and novel influenza and improve pandemic preparedness and response.
Leidos is seeking a motivated, detail-oriented, organized candidate to support the Laboratory Quality Management System (LQMS) which includes monitoring the quality of serologic and diagnostic testing of evolving influenza viruses to ensure that developed influenza diagnostics and reagents meet quality standards and vaccines elicit protective responses to novel, current epidemic or pandemic influenza viruses. This includes monitoring assay performance, equipment monitoring, reagent lot testing, and other quality tasks. In addition, ongoing maintenance of the capacity to rapidly assess and develop readily available reagents and assays for response is a critical component of pandemic preparedness and response. This position is contingent upon contract award.
- Monitoring quality of serological and diagnostic testing of evolving influenza viruses
- Ensuring that developed influenza diagnostics and reagents meet quality standards
- Ensuring developed vaccines elicit protective responses to current epidemic or pandemic influenza viruses
- Coordinate with senior managers, technical team members and other staff to implement quality assurance methods, processes, audits, and documentation.
- Facilitating the transfer of resources to research and surveillance
- Maintaining compliance with National Center for Immunization and Respiratory Diseases’ (NCIRDs) Laboratory Quality Management System (LQMS) program to meet requirements as well as all applicable CLIA, GLP, GMP and FDA regulatory requirements
- Collecting, evaluating and summarizing laboratory data in a format compliant for FDA Pre-Submissions, In Vitro Diagnostic Devices (IVD), 510(k) submissions for FDA clearance and Emergency Use Authorizations (EUA)
- Facilitating FDA interactions regarding regulatory submissions
- Conducting site visits and quality audits at collaborative partner facilities
A Master’s degree in biology, life sciences or a related discipline
- 3-5 years related experience planning, implementing and maintaining quality assurance programs
- Must be able to obtain and hold a Public Trust Security Clearance
- CDC customer experience and knowledge of their organizational structure
- Certified Quality Auditor certification preferred
External Referral Bonus:Ineligible
Potential for Telework:No
Clearance Level Required:Public Trust
Travel:Yes, 10% of the time
Scheduled Weekly Hours:40
Job Family:Life Scientist2000Health
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.
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