National PAHO Consultant - Especialista en Sistemas de Gestión de Calidad de Laboratorios
Organizational Context
The Pan American Health Organization (PAHO) serves as the Regional Office for the Americas of the World Health Organization (WHO).
Job Purpose
Provide specialized technical assistance to the National Laboratory of Health Surveillance (LNV) to strengthen the implementation of its Quality Management System, address identified non-conformities, enhance staff competencies, and develop technical processes for accreditation of prioritized tests according to OHN ISO 15189:2022.
Responsibilities
Analyze technical non-conformities and support corrective actions. Develop and update a Quality Management System strengthening plan. Provide technical assistance for the review, update, and standardization of Quality Management System documentation. Strengthen document management, including the organization of the document repository. Analyze the feasibility of tests for accreditation and provide prioritization recommendations. Provide technical assistance for method verification, uncertainty estimation, and metrological traceability. Develop or update procedures, protocols, and technical tools for prioritized tests. Design and implement capacity-building activities for LNV staff. Plan, coordinate, and participate in internal audits of the Quality Management System. Support the identification and follow-up of corrective actions and improvement opportunities. Identify and systematize technical, documentary, and metrological needs for accreditation. Maintain a follow-up mechanism for non-conformities and corrective actions. Strengthen knowledge transfer and institutional appropriation of implemented tools and processes. Prepare technical products and reports.
Work Experience
Essential: Minimum five years of professional experience in clinical laboratories, quality management, or related areas. Experience in implementing, maintaining, evaluating, or strengthening laboratory Quality Management Systems. Experience in applying ISO 15189 and/or preparing laboratories for accreditation. Experience in analyzing and addressing non-conformities and corrective actions. Demonstrated experience in analytical method verification and processes related to uncertainty estimation and/or metrological traceability. Demonstrated experience in internal audits of laboratory Quality Management Systems. Desirable: Training or certification as an internal or lead auditor of Quality Management Systems, preferably with experience in clinical laboratories.
Skills
Skills: Ability to analyze, implement, and strengthen laboratory Quality Management Systems. Ability to identify, analyze, and track gaps, non-conformities, and corrective actions. Ability to develop, review, and standardize procedures, protocols, records, and technical documentation. Ability to develop processes for method verification, uncertainty estimation, and metrological traceability. Ability to plan, organize, and execute internal audits of Quality Management Systems. Ability to design and implement training and knowledge transfer activities. Analytical skills, information systematization, and technical report writing. Ability to work collaboratively with technical and multidisciplinary teams. Knowledge: ISO 15189:2022 and its application in clinical laboratories. Quality Management Systems for laboratories. Laboratory accreditation processes and requirements. Analytical method verification. Measurement uncertainty estimation. Metrological traceability and management. Internal audits and ISO 19011. Document management and control. Non-conformity analysis, corrective actions, and continuous improvement. Tools for data analysis related to quality processes.