Quality Assurance Analyst

2 weeks ago


North Chicago, Illinois, United States Select Source International Full time
Descripción del TrabajoTítulo del Trabajo:
Analista de Aseguramiento de Calidad


Ubicación:
Abbott Park, IL


Duración: Contrato de 12 meses (con posible extensión)

Tarifa: $29.00/hora

Horario - 8:00am-4:00pm (de lunes a viernes)

Descripción del Trabajo
Encargado de realizar pruebas de calidad bioanalítica dentro del sistema QIMS y SAP. Proporciona insumos para facilitar investigaciones de CAPA según sea necesario. Es responsable de aprobar cualquier evento de prueba. Mantiene el inventario de productos y pruebas, cumpliendo con el sistema de calidad. Desempeña el papel de Técnico de Calidad II y ejecuta actividades diarias con supervisión mínima. Se convierte en un punto de contacto para problemas de laboratorio y puede ser llamado para ayudar con actividades de programación. Proporciona insumos sobre pruebas y es un SME (Experto en la Materia) en sus certificaciones.

Responsabilidades Clave del Trabajo
  • Implementar y mantener la efectividad del sistema de calidad.
  • Requisitos Básicos – Realiza pruebas de calidad en un entorno de laboratorio de alta velocidad y posee múltiples certificaciones.
  • Experiencia con técnicas bioanalíticas como: HPLC, SDS-PAGE, Western Blot, Dot Blot, Espectroscopía Infrarroja, Absorbancia UV-Vis, ELISA, Espectrometría de Masas (MS), métodos de microplacas.
  • CAPA - Investiga resultados de pruebas fuera de tolerancia y especificación, incluyendo quejas. Apoya el proceso de tendencia de tickets y mantiene registros de calidad.
  • Comunicación - Comunica y colabora de manera efectiva dentro del equipo y con la gerencia.
  • Documentación - Mantiene documentos y registros precisos y completos.
  • Gestión de Mejoras de Producto y Proceso - Participa en actividades de proyectos y mejoras de procesos. Monitorea el rendimiento de los procesos de prueba, implementa mejoras y fomenta una cultura de mejora continua. Proporciona apoyo de calidad a procesos clave y proyectos de desarrollo/mejora de productos. Toma la iniciativa en el laboratorio para asegurar que se ejecuten las Buenas Prácticas de Manufactura (GMP) y las Buenas Prácticas de Laboratorio (GLP) y que el laboratorio funcione de manera eficiente.
  • Gestión de Sistemas Informáticos - Mantiene y actualiza aplicaciones informáticas relevantes.
  • Calidad/Conformidad - Apoya las operaciones de manufactura y pruebas según sea necesario, cumpliendo con GMP y GLP. Posee un entendimiento básico del Sistema de Calidad, incluyendo los subsistemas y está familiarizado con los procesos clave del Sistema de Calidad. Se mantiene al tanto de los estándares que regulan nuestra industria. Participa y realiza todas las capacitaciones y revisiones requeridas en el Sistema de Gestión de Aprendizaje ISOtrain. Realiza negocios de manera que proteja la salud humana, la seguridad y el medio ambiente cumpliendo con todas las leyes aplicables de EHS, así como con los estándares globales y técnicos de Abbott. Cumple con los requisitos del Sistema de Calidad de Abbott.
  • Compartir Conocimiento de Calidad - Comparte conocimientos de calidad, colaborando con colegas dentro del equipo.
  • Capacitación - Realiza todas las capacitaciones y revisiones requeridas.
  • Almacenamiento de Muestras y Archivos - Asegura el almacenamiento de muestras y documentos en los sistemas de archivo apropiados.
  • Seguridad en el Laboratorio – Participa en la seguridad del laboratorio.

Descripción de la Empresa: Select Source International (SSI) es una firma de consultoría en Servicios de TI, Salud y Ingeniería que ha estado en funcionamiento desde 1998.

Los consultores de SSI han proporcionado servicios excepcionales que han sido apreciados por clientes, consumidores y usuarios en varias grandes empresas Fortune 500, empresas de tamaño mediano y firmas de consultoría.



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