Laboratory Quality Specialist III

• Assist with the development, implementation, and annual assessment of the laboratory Quality Assurance program.
• Review all laboratory quality occurrence data; provide reports to include specific monitors as defined by the Manager/Director, and graphical data to department management, clients, and customers.
• As the document control officer for Laboratory Services procedures, ensure annual review, and approve all policies.
• Coordinate CDC’s point-of-care (POC) testing program activities, including equipment evaluation, policy development, and implementation/monitoring of quality control.
• Prepare, implement, and initiate laboratory policy and procedures review, conducting literature searches to ensure regulatory agency requirements are addressed and met.
• Coordinate department activities necessary for all accreditation and governmental agency standards.
• Manage equipment maintenance, documentation, cleaning, and decontamination for repair.
• Coordinate third-party vendor maintenance contract activities.
• Upload ELIMS with equipment and link to rooms.
• Document and complete non-conforming event steps, utilizing the NCE database.
• Monitor the daily temperature, using data loggers and liquid in glass thermometers.
• Download temperature deviations using the USB Easy Log Software.
• Coordinate the validation and implementation of new testing and instrumentation.
• Create and deliver formal and informal committee meeting presentations and educational programs.
• Direct meetings and discussions with coordinators and staff in developing strategy and action plans for programs/projects.
• Serve as primary point of contact with client quality managers.
• Analyze and respond to Risk Management inquiries, unusual incident reports, and client concerns.
• Perform other duties as assigned, which include assisting with staffing needs across the service line as competencies allow.

• Minimum 5 years of laboratory experience in laboratory QA/QC methods, preferably in a Current Good Manufacturing (cGMP) environment.
• Training and/or working experience with quality management, quality assurance, quality audit, CAPA, LSRB, OLSS, and CLIA compliance.
• Prior experience supporting BSL-3 program and expert knowledge in high containment practices.
• Experience in triaging feedback, complaints, non-conforming events, CAPA, and/or document control systems ensuring compliance to established procedures.
• Ability to obtain necessary immunizations, including but not limited to, Hepatitis B, as required for the work environment.
• Ability to obtain government clearance.
• Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.

Demonstrates extensive experience in laboratory Quality Assurance and Quality Control (QA/QC) methods, with a strong focus on compliance with regulatory standards such as cGMP, CAPA, and CLIA. Capable of managing laboratory policies, coordinating accreditation activities, and effectively communicating with clients and stakeholders.

• Laboratory Quality Assurance
• Quality Management Systems
• CAPA Implementation
• BSL-3 Program Support
• Regulatory Compliance

• Quality Assurance Methods
• Quality Control Procedures
• Document Control Systems
• Temperature Monitoring
• Data Analysis

• Communication Skills
• Problem-Solving
• Team Coordination
• Presentation Skills

• Hepatitis B Immunization
• Government Clearance

• Current Good Manufacturing Practices
• CLIA Compliance
• High Containment Practices
• Accreditation Standards

• USB Easy Log Software
• NCE Database
• Data Loggers