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Ubicación:
San Diego
Categoría:
Gestión de Registros y Control Documental

Workable
Especialista en Control de Documentos
¿Quién es CorDx?
CorDx es una organización biotecnológica multinacional centrada en expandir los límites de la innovación y el suministro en salud global. Con más de 2.100 empleados en todo el mundo, que atienden a millones de usuarios en más de 100 países, CorDx ofrece soluciones de pruebas rápidas y dispositivos médicos de diagnóstico en el punto de atención utilizados en la detección de enfermedades infecciosas como la COVID-19, embarazo, drogas de abuso, biomarcadores y más. CorDx está a la vanguardia de la tecnología, la inteligencia artificial y la ciencia de datos con el objetivo de ofrecer soluciones diagnósticas para algunas de las preguntas más críticas en el ámbito sanitario.
Tipo de empleo: Tiempo completo
Título del puesto: Especialista en Control de Documentos
Ubicación: Híbrido - San Diego
Rango salarial: $70,000 - $75,000
Resumen del puesto:
El Especialista en Control de Documentos es responsable de gestionar el flujo y almacenamiento de todos los documentos controlados dentro de la organización. Este puesto se encarga de garantizar que los documentos sean precisos, estén actualizados y estén disponibles para todos los empleados que los necesiten. El especialista mantendrá el sistema de gestión de documentos Master Control, asegurará el cumplimiento de los requisitos regulatorios y apoyará iniciativas de mejora continua relacionadas con el control de documentos.
Responsabilidades principales:
Gestión de documentos:
Gestionar la creación, revisión, distribución y archivo de documentos controlados, incluyendo SOP, instrucciones de trabajo, formularios y otra documentación relacionada con la calidad.
Asegurar que todos los documentos estén debidamente etiquetados, indexados y almacenados en el sistema de gestión de documentos (Master Control).
Coordinar los procesos de revisión y aprobación de documentos, garantizando actualizaciones oportunas y cumplimiento con los procedimientos internos.
Cumplimiento y aseguramiento de calidad:
Asegurar que todos los documentos controlados cumplan con las normas regulatorias aplicables (por ejemplo, ISO 13485, FDA 21 CFR Parte 820) y las políticas de la empresa.
Participar en auditorías internas y externas, brindando apoyo en control de documentos y asegurando que la documentación esté disponible para su inspección.
Ayudar en el desarrollo y mantenimiento de procedimientos, plantillas y directrices de control de documentos.
Administración del sistema:
Mantener y administrar el sistema electrónico de gestión de documentos Master Control, asegurando que el acceso de usuarios esté controlado y que el sistema funcione eficazmente.
Capacitar al personal en los procedimientos de control de documentos y en el uso del sistema de gestión de documentos.
Supervisar y registrar los cambios en los documentos, asegurando el control de versiones y la eliminación de documentos obsoletos de la circulación.
Mejora continua:
Identificar oportunidades de mejora en las funciones de control de documentos y contribuir a la implementación de mejores prácticas.
Colaborar con otros departamentos para optimizar los flujos de trabajo de documentos y aumentar la eficiencia.
Apoyar el desarrollo e implementación de métricas de control de documentos para monitorear el rendimiento del sistema y el cumplimiento.
Comunicación y soporte:
Actuar como punto de contacto principal para consultas sobre control de documentos, brindando orientación y apoyo al personal.
Asegurar una comunicación efectiva de las actualizaciones y cambios de documentos en toda la organización.
Requisitos
Educación:
Título universitario en un campo relacionado (por ejemplo, Gestión de Calidad, Asuntos Regulatorios, Administración de Empresas) o experiencia equivalente.
Experiencia:
Mínimo 2 años de experiencia en control de documentos, aseguramiento de calidad o un puesto relacionado dentro de una industria regulada (por ejemplo, dispositivos médicos, productos farmacéuticos, biotecnología).
Conocimiento del uso de sistemas de gestión de documentos y sistemas de gestión de calidad.
Experiencia práctica con Master Control.
Habilidades:
Gran atención al detalle y habilidades organizativas.
Excelentes habilidades de comunicación escrita y verbal.
Capacidad para gestionar múltiples tareas y priorizar eficazmente en un entorno dinámico.
Dominio del paquete Microsoft Office (Word, Excel, PowerPoint) y software de gestión de documentos.
Conocimiento de normas regulatorias como ISO 13485, FDA 21 CFR Parte 820 y otras regulaciones aplicables.
Beneficios
Plan de seguro médico
Plan de jubilación
Tiempo libre remunerado
Capacitación y desarrollo
Somos un empleador que ofrece igualdad de oportunidades y celebramos la diversidad, reconociendo que la diversidad de pensamiento y antecedentes construye equipos más fuertes. Abordamos la diversidad y la inclusión con seriedad y reflexión. No discriminamos por raza, religión, color, ascendencia, origen nacional, casta, sexo, orientación sexual, género, identidad o expresión de género, edad, discapacidad, condición médica, embarazo, composición genética, estado civil o servicio militar.

San Diego, CA, USA
$70,000-75,000/año
Puestos populares
Ciudades populares