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Analyst Documentation Control

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Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.


• Este rol trabaja en conjunto con el ingeniero(a) o supervisor(a) de calidad de control de documentación para dar soporte en el análisis, ejecución y gestión de los procesos administrados por el departamento de documentación en cumplimiento al sistema de calidad.

1. Vigila el cumplimiento de los requisitos de la regulación FDA de países a donde se exporta el producto, estándares internaciones ISO 13485 y requisitos corporativos, así como también, dar cumplimiento al proceso de la administración del riesgo en lo relacionado al control y manejo del archivo documental del SGC, cuando aplique.

2. Administra las actividades del sistema de manejo de registros y documentos (SoR), garantizando que el alta, actualización, obsolescencia y baja de documentos se realice mediante la administración efectiva del Sistema de Control de Documentación y detecta desviaciones en el proceso de manera preventiva.

3. Monitorea el correcto procesamiento y seguimiento para asegurar la actualización de revisión periódica de los documentos vigentes en cada área.

4. Ejecuta actividades para ingreso de alta, modificación, obsolescencia de números de parte, BOMs y rutas en los ERPs del Sitio de Tijuana.

5. Analiza y lleva de manera específica el métrico con frecuencia semanal para el adecuado seguimiento de la logística y cumplimiento en tiempo, del control del cambio por cada documento.

6. Participa en las actividades y entrenamientos relacionados a las Buenas Prácticas de Documentación (GDPs).

7. Digitaliza, controla, mantiene y resguarda el archivo electrónico y físico (DHRs, protocolos de validaciones y documentos regulatorios que apliquen) asegurando los periodos de retención correctos para los documentos dentro del archivo físico, de acuerdo con las políticas y procedimientos relacionados para el SGC.

8. Distribuye a los diferentes departamentos las copias controladas de documentos maestros y mantiene registros correspondientes de dicha distribución.

9. Realiza la compra de insumos requeridos para el área de documentación y pago a proveedores.

10. Apoya el cumplimiento del Sistema de Calidad mediante su participación en actividades adicionales y requeridas por el jefe inmediato como en investigaciones mediante la implementación de las actividades relacionadas al seguimiento de un NCR/CAPA asociados al área y se involucra en auditorías internas y externas del SGC.

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