The Quality Assurance (QA) Specialist will support laboratory quality and compliance efforts across a diverse range of CDC scientific and research laboratories. This position involves developing, implementing, and sustaining Quality Management Systems (QMS) in alignment with federal regulations and international standards. The QA Specialist will act as a consultant, educator, and technical advisor to CDC laboratory and program staff, and will play a critical role in strategic planning, risk management, audit readiness, and continuous quality improvement initiatives. Requires a NACI Public Trust or the ability to obtain one. Compensation & Benefits: Estimated Starting Salary Range for Quality Assurance (QA) Specialist: Pay commensurate with experience. Full time benefits include Medical, Dental, Vision, 401K, and other possible benefits as provided. Benefits are subject to change with or without notice. Quality Assurance (QA) Specialist Responsibilities Include:
Quality Systems Implementation & Support
Provide consultation and technical support to CDC laboratory staff, quality managers, and senior scientists in implementing and maintaining Quality Management Systems (QMS). Translate complex quality and regulatory requirements (e.g., Code of Federal Regulations, ISO 17025/15189, CLIA, GxP standards) into actionable practices for laboratory personnel. Develop and implement strategic QMS plans, tailored to laboratory functions including diagnostic testing, surveillance, research, product development, and manufacturing.
Audit Readiness & Regulatory Compliance
Guide laboratories in preparing for internal and external audits, ensuring readiness for inspections from accrediting or regulatory agencies (e.g., CAP, CMS, FDA). Conduct GAP analyses to identify areas for improvement and ensure alignment with quality and regulatory expectations. Generate and review Nonconformance Events (NCEs) and assist in drafting and tracking Corrective and Preventive Action Plans (CAPAs).
Risk Management & Safety
Draft, review, and support the clearance process for risk assessments related to laboratory processes, equipment, and personnel safety. Communicate and promote agency-wide quality and safety initiatives to laboratory staff and stakeholders, ensuring alignment with CDC policies.
Training & Communication
Provide training and mentorship on QMS principles to quality managers, laboratory technicians, research scientists, and support staff. Assist with developing training materials, SOPs, job aids, and other QMS documentation. Serve as a liaison between laboratory personnel and agency leadership to ensure consistent quality practices across laboratory branches.
Performs other job-related duties as assigned
Quality Assurance (QA) Specialist Experience, Education, Skills, Abilities requested:
- Bachelor's degree in Biology, Laboratory Science, Public Health, Quality Assurance, or a related field.
- 3-5+ years of experience in quality assurance within a laboratory, healthcare, or public health environment.
- Deep understanding of QMS principles, regulatory requirements, and accreditation standards (e.g., CLIA, CAP, ISO, FDA).
- Experience conducting audits, risk assessments, and GAP analyses.
- Excellent communication, facilitation, and project management skills.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Preferred Qualifications:
- Advanced degree (e.g., MPH, MS, or MBA) in a relevant discipline.
- Certification in quality management or auditing (e.g., ASQ CQA, RAC, ISO Lead Auditor).
- Prior experience supporting CDC or federal laboratory quality programs.
- Familiarity with Good Laboratory Practices (GLP), Good Clinical Practices (GCP), or Good Manufacturing Practices (GMP).
- Must pass pre-employment qualifications of Cherokee Federal
Company Information: Cherokee Nation Operation Solutions (CNOS) is a part of Cherokee Federal - the division of tribally owned federal contracting companies owned by Cherokee Nation Businesses. As a trusted partner for more than 60 federal clients, Cherokee Federal LLCs are focused on building a brighter future, solving complex challenges, and serving the government's mission with compassion and heart. To learn more about CNOS, visit cherokee-federal.com. #CherokeeFederal #LI Cherokee Federal is a military friendly employer. Veterans and active military transitioning to civilian status are encouraged to apply. Keywords:
- Quality Management Systems (QMS)
- Regulatory Compliance
- Laboratory Accreditation
- Audit Readiness
- Risk Assessment
Similar Job Titles:
- Laboratory Quality Specialist
- QA/QC Analyst
- Quality Systems Coordinator
- Compliance and Quality Assurance Officer
- Clinical Laboratory Quality Manager
Legal Disclaimer: All qualified applicants will receive consideration for employment without regard to protected veteran status, disability or any other status protected under applicable federal, state or local law. Many of our job openings require access to government buildings or military installations. Candidates must pass pre-employment qualifications of Cherokee Federal. Many of our job openings require access to government buildings or military installations. Candidates must pass pre-employment qualifications of Cherokee Federal. Please Note: This position is pending a contract award. If you are interested in a future with Cherokee Federal, APPLY TODAY! Although this is not an approved position, we are accepting applications for this future and anticipated need.
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