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Job #: R-00015238
Location: Fort McPherson, GA
Category: Life Scientist
Schedule (FT/PT): Full Time
Travel Required: Yes, 10% of the time
Shift: Day
Potential for Telework: No
Clearance Required: Public Trust
Referral Eligibility: Ineligible
Group: Health

Description

Job Requisition:

Biological Scientist-Quality Assurance Specialist

Job Description:

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.

Primary Responsibilities

  • 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
  • Basic Qualifications

    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
  • Preferred Qualifications

  • 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

Shift:

Day

Requisition Category:

Professional

Job Family:

Life Scientist

2000

Health

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.

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.

Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to spam.leidos@leidos.com.

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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