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Lead Operations Analyst

2 months ago

Athens, Georgia, United States Cynet Systems Full time
Descripción del Trabajo:

Responsabilidades:
  • Proporcionar soporte principal en la producción en el área asignada.
  • Planificar, preparar, emitir y controlar el cronograma de producción y los requisitos de material para asegurar un flujo controlado de material aprobado que cumpla con el plan de producción.
  • Facilitar la implementación del plan de producción.
  • Tomar medidas correctivas ante problemas operativos diarios dentro del departamento.
  • Actuar como experto en la materia (SME), brindando orientación sobre desviaciones, investigaciones y problemas relacionados con la calidad del producto.
  • Estudiar la necesidad de mejoras en los procesos, sistemas y equipos existentes, y en cooperación con departamentos relacionados, llevar a cabo optimizaciones para aumentar la eficiencia y calidad, y reducir costos.
  • Recomendar e implementar medidas correctivas/preventivas destinadas a mejorar el cumplimiento y reducir la recurrencia de problemas.
  • Proporcionar soporte técnico para la investigación y resolución de desviaciones y eventos atípicos, colaborando con Aseguramiento de Calidad para garantizar que se mantengan estándares de calidad consistentes.
  • Rastrear desviaciones, eventos y parámetros clave del proceso, y proporcionar informes a la dirección sobre tendencias y estado según se solicite. Recomendar acciones correctivas para cualquier tendencia identificada.
  • Identificar e implementar mejoras de procesos relacionadas con la seguridad, medio ambiente, calidad, cumplimiento, productividad, rendimiento y costo.
  • Asegurar el cumplimiento regulatorio y la viabilidad técnica de los cambios propuestos.
  • Iniciar y ejecutar controles de cambio para proyectos.
  • Recuperar y utilizar datos para monitorear el rendimiento del proceso y solucionar proactivamente problemas operativos.
  • Colaborar con Automatización y Gestión de Información para mejorar la efectividad de la recolección y análisis de datos del proceso.
  • Asegurar el cumplimiento de calidad y seguridad del departamento.
  • Planificar y dirigir la administración e implementación de proyectos asignados según sea necesario para la fabricación de los productos de la empresa.
  • Vivir nuestro Credo y Propósito poniendo las necesidades de nuestros interesados primero, persiguiendo los más altos estándares de cumplimiento, calidad y ética.
  • Conectar de manera inclusiva dentro del departamento, con otros departamentos y dentro de la empresa para abordar las necesidades del cliente.
  • Dar forma al futuro a través de la innovación, inspirando nuevas ideas, probando cosas nuevas y demostrando resiliencia y agilidad para adaptarse al cambio.
  • Crecer desarrollando a uno mismo y a otros para alcanzar metas mediante conversaciones abiertas y honestas, gestionando la energía y asumiendo la responsabilidad de los resultados.
Requisitos:
  • Proporcionar soporte documental para revisiones de SOP/Registros de Lotes.
  • Identificar cambios necesarios en documentos y asegurar la revisión oportuna de todos los SOP y registros de lotes.
  • Revisar y aprobar revisiones de SOP y registros de lotes.
  • Asistir con el inicio de equipos y capacitación técnica según sea necesario.
  • Proporcionar soporte técnico para el mantenimiento y verificación de validación de procesos y limpieza.
  • Asistir con la optimización del ciclo de limpieza y esfuerzos de revalidación.
  • Demostrar experiencia en las siguientes áreas: cGMPs, regulaciones de la FDA, procesos de fabricación, equipos de fabricación, sistemas de agua de alta pureza y utilidades.
  • Ser responsable del manejo de sustancias controladas en cumplimiento con las leyes y requisitos estatales y locales aplicables.
Calificación:
  • Educación secundaria/GED más dos años de educación/titulación técnica formal o equivalente.
  • Se prefiere título universitario en ciencias.
Experiencia y Habilidades:
  • Generalmente, de 4 a 6 años de experiencia laboral en una industria de fabricación química, farmacéutica, de dispositivos médicos o similarmente regulada.
  • Capacidad para aprender y operar SAP Production, COMET, SUMMIT, al nivel requerido.
  • Comprensión técnica de al menos un área de procesamiento.
  • Capacidad para leer, analizar e interpretar manuales de procedimientos, revistas científicas y técnicas comunes, informes financieros básicos y documentos legales, publicaciones periódicas de negocios generales y regulaciones gubernamentales.
  • Capacidad para responder a consultas sensibles y presentar información a la Dirección del Sitio, agencias reguladoras y miembros de la comunidad empresarial.
  • Capacidad para definir problemas, recopilar datos e información relevantes, establecer hechos y llegar a conclusiones válidas según sea necesario.
  • Capacidad para interpretar una variedad de instrucciones proporcionadas en forma escrita, oral, de diagrama o de programación.
  • Demostrada capacidad para escribir de manera efectiva para comunicar el trabajo preparado, racionalizar conclusiones y recomendaciones, y documentar de manera conforme para organismos reguladores.
  • Gestionar y coordinar múltiples prioridades de proyectos según sea necesario.
  • Capacidad para trabajar de manera independiente en tareas rutinarias y no rutinarias.
  • Completar con éxito los requisitos de capacitación regulatoria y laboral.
  • Mantenerse al día en habilidades y tendencias de la industria.
Preferido:
  • Experiencia con SAP y Minitab.
  • Experiencia con sistemas de control de procesos (por ejemplo, PCS 7, Emerson DeltaV) y software de historiador de datos (por ejemplo, OSi PI).
  • Sólido entendimiento de Word, PowerPoint y Excel.