Quality Assurance Specialist - Goldbelt, Inc.

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs. 

Summary:

Goldbelt Professional Services, LLC (GPS) is seeking a detail-oriented Quality Assurance Specialist to join our team, supporting laboratory quality and safety initiatives at the Centers for Disease Control and Prevention (CDC). The CDC is the nation’s premier health promotion, prevention, and preparedness agency. This role focuses on strengthening laboratory infrastructure, enhancing safety culture, and ensuring compliance with national and international quality standards through strategic planning, consultancy, and training.

Essential Job Functions:

• Quality Management Implementation
  • Develop and implement quality management systems (QMS) within diverse laboratory environments, ensuring alignment with leadership requirements.
  • Translate regulatory quality requirements (CFR, international/national standards) into actionable laboratory practices, tailoring to scientific modalities.
• Training and Consultation
  • Provide specialized training and consultations for quality managers, senior scientists, and laboratory staff to enhance compliance and safety practices.
  • Act as a quality point of contact for addressing equipment management issues, including calibration, temperature monitoring, and humidity control.
• System and Policy Development
  • Lead the development and revision of SOPs, quality policies, and procedural documentation to meet evolving laboratory needs.
  • Support the migration and integration of documentation into new management systems.
• Strategic Planning and Management
  • Collaborate with cross-functional teams to plan and execute QMS strategies, including equipment management, corrective actions, and procedural updates. Oversee the integration of equipment preventative maintenance requirements into inventory systems.
• Audit and Compliance Oversight
  • Conduct internal assessments to ensure adherence to CLIA, CMS, and other regulatory standards.
  • Manage corrective action processes, including root cause analysis and resolution for equipment failures and environmental issues.
• Stakeholder Collaboration
  • Liaise with laboratory leadership and external partners to address quality assurance issues, provide technical support, and resolve data discrepancies.

Necessary Skills and Knowledge:

• Strong understanding of laboratory quality management systems (QMS) and regulatory frameworks (CFR, CLIA, CMS).
• Expertise in equipment management, including calibration, preventative maintenance, and environmental monitoring.
• Proficiency in drafting, reviewing, and implementing SOPs and procedural documentation.
• Excellent communication and training skills, with the ability to translate complex regulations into actionable guidance.

Minimum Qualifications:

• Bachelor’s degree in a scientific or technical discipline.
• 3-5 years of experience in laboratory quality assurance or related fields.
• Knowledge of laboratory operations across research, diagnostic, and surveillance environments.

Preferred Qualifications:

• Master’s degree in a relevant field with advanced certification in quality management (e.g., ASQ, Six Sigma).
• Experience working with CDC or similar public health organizations.
• Familiarity with laboratory information management systems (LIMS) and document management systems.

Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.