Quality Assurance Specialist

hace 6 días


San José, San José, Costa Rica Abbott A tiempo completo

The Quality Assurance Specialist role at Abbott is an exciting opportunity to ensure the quality and technical validity of laboratory analyses while safeguarding the health of staff and the community. The position is based in the Core Lab Division in San Jose, Costa Rica, and requires adequate support for the quality system to comply with Abbott policies, external standards, and regulations.

Key Responsibilities:

1. Assure compliance for product labeling process at Costa Rica Abbott warehouse.
2. Ensure the correct performance of operations at Abbott Warehouse to safeguard the quality and technical validity of the analyzes and prevent risks to the health of staff or the community.
3. Support in the execution of Field Actions and communication of Product Information for DxCAM.
4. Maintenance of supplier control in accordance with the requirements of the Diagnostics Division.
5. Conduct audits of high-risk service providers for DxCAM.
6. Support and represent Abbott in audits carried out by Abbott and the Ministry of Health in Costa Rica for the Abbott Diagnostics Division.
7. Quality responsible for Product release for commercialization at the Costa Rica warehouse.
8. Monitor and audit Good Distribution Practices and Good Storage Practices, locally and in countries of DxCAM region.
9. Execution in non-conformity management system and develop Corrective and Preventive Actions to avoid their recurrence.

Requirements:

The ideal candidate will have a degree in Health sciences as Clinical chemical microbiologist, and at least 3 years of experience in Manufacturing industry of chemicals, pharmaceuticals, medical devices, chemicals, storage and distribution. Regulatory agencies for chemical substances, medical devices, and positions as Coordinator or supervisor of quality processes or labeling operations are also required. Additionally, knowledge in local Regulatory/Techno vigilance guidelines for Central America and Caribbean countries and fully bilingual English Spanish are necessary. Travel and fieldwork are also part of the role, approximately 2 travels per year and 15% fieldwork, 85% office work.



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