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Quality Assurance Technician V
hace 2 semanas
OBJETIVO DE LA POSICION:
Realizar y registrar de forma adecuada y oportuna las tareas relacionadas con el monitoreo ambiental del proceso/producto, requeridos de acuerdo con los procedimientos oficiales.
RESPONSABILIDADES CLAVE:
DESCRIBA EL ALCANCE:
Realizar las tareas rutinarias y no rutinarias (intrusiones) de monitoreo ambiental
de los cuartos de producción controlados y de los sistemas críticos de acuerdo con
los procedimientos oficiales correspondientes. Esto incluye superficies,
microorganismos en aire, partículas en aire, aire comprimido y monitoreo de agua.
20 %
Realizar las pruebas rutinarias de bioburden (carga microbiana) y endotoxina a
muestras de producto/agua de acuerdo con los procedimientos oficiales
correspondientes.
15 %
Realizar los registros de datos correspondientes de acuerdo con los
procedimientos oficiales siguiendo las buenas prácticas de documentación. Lo
anterior incluye documentación de condiciones de pruebas y parámetros, lectura
de resultados, entre otros.
15%
Realizar notificación oportuna de resultados no aceptables (o condiciones
anormales) relacionados con monitoreos ambientales y dar seguimiento
adecuado a las pruebas requeridas según los procedimientos oficiales
correspondientes. Lo anterior incluye soporte durante investigaciones del
Laboratorio de Microbiología.
Según sea
requerido
Realizar tareas de monitoreo/procesamiento de pruebas cuando sea requerido
como soporte a estudios o proyectos (validación de métodos de laboratorio,
procesamiento de indicadores biológicos, validaciones relacionadas con cambios
en el proceso/producto, entre otros).
10%
Soporte en redacción de protocolos y estudios de laboratorio cuando sea
requerido
5%
Mantener ordenados los suministros, equipos y documentación de acuerdo con
las 5S.
5%
Allergan Propietary Information General
RESPONSABILIDADES CLAVE:
DESCRIBA EL ALCANCE:
% del tiempo o
Importancia
Organizar y compilar información requerida para análisis de tendencia mensual
(OMR).
10%
Controlar inventario del laboratorio y realizar compra oportuna de suministros,
según necesidades del área.
15%
Dar soporte durante el entrenamiento de personal de nuevo del Laboratorio de
Microbiología y realizar entrenamiento de inducción del personal de nuevo ingreso
a la planta en temas microbiológicos (control de contaminación, comportamiento
adecuado dentro del cuarto limpio).
5%
Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS,
mediante el acatamiento de la política y los procedimientos internos. Así mismo,
garantizar el cumplimiento mediante la adopción de estrategias, controles internos
comunicación y entrenamientos necesarios.
Según sea
requerido
Mejorar continuamente los resultados de EHS a través del liderazgo, el
compromiso y la participación activa en todas las iniciativas relacionadas con
Educación y Experiência
Bachiller en Microbiología, Biotecnología, Químico o carrera afín.
Al menos dos años de experiência en tareas de monitoreo ambiental, producto y tareas relacionadas
con el desempeño de un laboratorio de microbiología.
Deseable experiência en empresas de manufactura de alimentos o de dispositivos médicos
HABILIDADES ESENCIALES:
Habilidades de liderazgo:
Estas habilidades evolucionan conforme la persona se mueve en
diferentes etapas laborales.
Otras habilidades profesionales:
Dominio de paquetes Office Requerido
Conocimiento de conceptos relacionados con Laboratorios de Microbiología
y/o Química (Buenas prácticas de Laboratorio, buenas prácticas de
documentación de datos de laboratorio, uso del microscopio, uso de
equipos de laboratorio de microbiología, preparación y manejo de medios
de cultivo, cálculo de diluciones, preparación de reactivos/soluciones, uso
de equipo de seguridad, entre otros).
Requerido
Sistemas de Gestión de Calidad (GMPs, QSRs, ISO, CAPA) Deseable
Inglés, nível intermedio Deseable
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