Laboratory Research Assistant

Research Laboratory Assistant/ Quality Management System (QMS) Specialist

Centers for Disease Control and Prevention

The Centers for Disease Control and Prevention (CDC), Division of HIV Prevention, is seeking laboratory professionals to support research activities aimed at reducing new HIV infections. This work supports clinical studies, surveillance, and implementation research by assisting with laboratory testing, analytical chemistry, and quality management processes. Depending on the role, candidates will either support analytical testing of biological specimens using advanced laboratory instrumentation (LC-MS/MS) or help maintain the laboratory's Quality Management System (QMS) to ensure compliance with CDC, CLIA, and other regulatory standards. These are full-time, onsite positions at the CDC campus in Atlanta, GA, supporting important public health research and laboratory operations.

Place of Performance: CDC, 1600 Clifton Road, Buildings 17 & 18, Atlanta, GA

Work Schedule: Monday–Friday, CDC Core Business Hours, 8:00 AM – 4:30 PM

Minimum Requirements:

• Bachelor's degree in: Medical Technology, Biological Sciences, or A related scientific discipline.
• Clinical or research laboratory experience or demonstrated expertise in laboratory quality and regulatory compliance through coursework or professional experience.
• Experience implementing, maintaining, or supporting a Quality Management System (QMS).
• Experience developing, maintaining, or monitoring laboratory Standard Operating Procedures (SOPs).
• Knowledge of laboratory quality regulations and standards, such as:

Clinical Laboratory Improvement Amendments (CLIA)

Clinical and Laboratory Standards Institute (CLSI)

College of American Pathologists (CAP)

International Organization for Standardization (ISO)

CDC Quality Manual for Microbiological Laboratories (QMML) or equivalent quality frameworks.

• Experience with document control and quality documentation.
• Ability to work onsite at the CDC laboratory in Atlanta, GA.

Preferred Experience

• Electronic Quality Management Systems (eQMS)
• Internal quality audits
• Corrective and Preventive Actions (CAPA)
• Equipment maintenance and calibration oversight
• Regulatory compliance
• Laboratory accreditation support
• Quality assessments and continuous improvement initiatives

Duties and Responsibilities:

• Support the implementation, maintenance, and continuous improvement of the laboratory Quality Management System (QMS).
• Work closely with the CDC Quality Manager and Safety Manager to ensure compliance with laboratory quality and regulatory requirements.
• Maintain knowledge of applicable laboratory standards and regulations, including CDC QMML, CLIA, CLSI, CAP, ISO, and other recognized quality standards.
• Implement and monitor quality policies, procedures, and processes using the 12 Quality System Essentials (QSEs).
• Manage document control activities, including creating, updating, reviewing, and maintaining quality procedures, forms, and Standard Operating Procedures (SOPs).
• Maintain and update quality documentation within the CDC electronic Quality Management System (eQMS).
• Coordinate quality-related activities with laboratory personnel and other CDC offices.
• Manage equipment maintenance and calibration activities by coordinating vendor services, obtaining quotations, preparing purchase requests, and tracking service documentation.
• Investigate laboratory nonconformance events and assist in developing, implementing, and documenting corrective actions.
• Conduct internal quality assessments and audits to verify compliance with laboratory policies, procedures, regulatory requirements, and quality standards.
• Monitor quality metrics and support continuous process improvement initiatives.
• Maintain records required for laboratory inspections, accreditation, and regulatory compliance activities.
• Assist in ensuring laboratory operations remain compliant with all applicable quality and safety requirements.