The OpportunityThis position works out of our location San Jose, Costa Rica in the Core Lab Division.
We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life.
Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.The Quality Assurance Specialist will ensure adequate support for the quality system, so that it complies with Abbott policies, the requirements of applicable external standards and regulations, providing support and monitoring of internal processes.
Supervision of the labeling process and Good Storage and Distribution Practices.What You'll DoAssure compliance for product labeling process at Costa Rica Abbott warehouse.Ensures the correct performance of operations at Abbott Warehouse in order to safeguard the quality and technical validity of the analyzes and prevent risks to the health of staff or the community.Support in the execution of Field Actions and communication of Product Information for DxCAM.Maintenance of supplier control in accordance with the requirements of the Diagnostics Division.
Conduct audits of high-risk service providers for DxCAM.Support and represent Abbott in audits carried out by Abbott and the Ministry of Health in Costa Rica for the Abbott Diagnostics Division.Quality responsible for Product release for commercialization at the Costa Rica warehouse.Monitor and audit Good Distribution Practices and Good Storage Practices, locally and in countries of DxCAM region.Execution in non-conformity management system and develop Corrective and Preventive Actions to avoid their recurrence.Technovigilance Abbott representative at Costa Rica Health Authority.Required QualificationsDegree in Health sciences as Clinical chemical microbiologist.College activated as Chemical microbiologist is mandatory.3 years minimum in Manufacturing industry of chemicals, pharmaceuticals, medical devices, chemicals, storage and distribution.
Regulatory agencies for chemical substances, medical devices.
In positions as Coordinator or supervisor of quality processes or labeling operations.Experience in good manufacturing practices, good storage practices and good distribution practices.Execution of Quality management system.Knowledge in local Regulatory/Techno vigilance guidelines for Central America and Caribbean countries.Fully bilingual English Spanish.Travel: Position requires travel just in case of assigned audit or project.
Approximately 2 travels per year.
Fieldwork: 15% fieldwork, 85% office work required.?