Laboratory Quality Control Specialist

Centers for Disease Control and Prevention • Fort Collins, CO

9d • Onsite

About The Position

This position is with the Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, headquartered in Atlanta, Georgia. The Laboratory Quality Control Specialist coordinates shipments of biological specimens, including special and hazardous items, and ensures that packaging and shipping comply with applicable laws, regulations, and CDC guidelines. The role conducts laboratory quality reviews, inspects workspaces for safety and regulatory compliance, and serves as the laboratory's primary liaison for audits, review committees, and third-party inquiries.

The incumbent must continually comply with applicable federal and state safety and health regulations and CDC/ATSDR policies. The position requires IATA certification within the first six months of hire, with recertification every two years, and the use of personal protective equipment and safety precautions as required by individual laboratories. Appointment is contingent on a negative drug test, and the position is subject to ongoing drug testing.

Requirements

• U.S. citizenship is required.
• Must meet the applicable Selective Service registration or exemption requirement for males born after December 31, 1959.
• Must be suitable for federal employment and successfully complete a background security investigation with favorable adjudication.
• Must pass a pre-employment drug test; the position is subject to random, reasonable-suspicion, and post-accident drug testing.
• Must meet all qualification requirements by the announcement closing date.
• Must have, or be able to obtain, IATA certification within six months of hire and maintain it with updates every two years.
• Must have a degree in biological sciences, agriculture, natural resource management, chemistry, or a related appropriate discipline, or equivalent courses plus appropriate experience or additional education.
• Must have one year of specialized experience equivalent to at least GS-09 performing all of the following: coordinating and routing complex biological, hazardous, and temperature-sensitive specimen shipments in compliance with transportation laws; conducting laboratory quality reviews and internal audits for compliance with standards and regulations such as CLIA, CLSI, or FDA; serving as a primary liaison for laboratory audits and external quality assessments; and independently planning and managing microbiology experiments and protocols, such as next-generation sequencing.
• Alternatively, must have a Ph.D. or three years of progressively higher-level graduate education leading to a Ph.D. or equivalent doctoral degree in an appropriate field, or a combination of graduate education and specialized experience that satisfies all qualification requirements.
• Foreign education used to meet qualification requirements must be evaluated as equivalent to an accredited U.S. education program, or receive full course credit from an accredited U.S. college or university.
• Federal salary payments must be made by direct deposit.
• A financial disclosure statement may be required; a probationary or trial period may be required.
• Resumes must not exceed two pages and should document exact employment dates and hours worked per week when relevant.

Responsibilities

• Coordinate shipments of biological specimens, including special and hazardous items, ensuring proper packaging and compliance with local, state, and federal laws, regulations, and CDC biological-shipping guidelines.
• Conduct ongoing laboratory quality reviews to assess compliance with quality-management systems, clinical laboratory practices, regulatory requirements, and national and international standards, including CLIA, CLSI, and FDA requirements.
• Routinely inspect and review assigned laboratory workspaces, identify and correct unsafe conditions, and ensure compliance with applicable safety regulations and laboratory policies.
• Serve as the laboratory's primary liaison for audits, review committees, and third-party inquiries.
• Continually comply with applicable federal and state safety and health regulations and established CDC/ATSDR policies.
• Obtain IATA certification within the first six months of hire and keep it updated every two years.
• Use personal protective equipment and observe safety precautions as required by individual laboratories.

Benefits

• Federal employee benefits package available to employees and their families, subject to position eligibility.
• Incentives may be authorized depending on factors including funding availability; possible incentives include moving expenses, recruitment or relocation incentives, student loan repayment, superior qualifications appointment, and creditable service for annual leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level