Assembler III

Aibonito, Puerto Rico
Temporary
Medical Device
Entry Level

QUALITY CONSULTING GROUP, líder en la industria farmacéutica, biotecnológica, de dispositivos médicos y de fabricación,está buscando un talento, altamente motivado y entusiasta para unirse a nuestro equipo. En este rol, trabajará con un  equipoaltamenteentusiasta, contribuyendo en una industria manufacturera de clase mundial en Puerto Rico y Estados Unidos. 

Responsabilidades:  

  • Responsable de verificar y cotejar que se cumplan con todos los requisitos de Calidad en los procesos de manufactura según las especificaciones, SOPs y de acuerdo a las Buenas Prácticas de Manufactura (GMP), Documentación (GDP) y documentos aplicables vigentes.
  • Verifica materiales y solventes según BOM.
  • Organizar, limpiar, sanitizar y mantener el área de trabajo según las normas y los estándares de producción y Sol 65.  
  • Inspecciona la producción para detectar defectos y lo preparara para el empaque de acuerdo con lo establecido en SOP y SPECs.
  • Realizar y participar en los re-trabajos del producto no conforme.
  • Maneja el proceso de empaque según los requerimientos de la especificación de producto.
  • Responsable del movimiento del producto ya terminado para ser empacado.
  • Operar maquinaria cuando sea requerido (suplir los materiales, documentación parámetros y pruebas etc.) según los Spec y SOP aplicables.
  • Preparar e imprimir etiquetas para el producto según los requerimientos de las especificaciones.
  • Verifica conteo de la totalidad del "batch" de producción.
  • Participar en corridas de protocolos, validaciones y en procesos de auditorías cuando son requeridos.
  • Asistir durante el proceso de línea clara (Line Clearence) en los cambios de código.
  • Muestrea e inspecciona el producto que se está manufacturando, según el BOM, "SPEC" y SOP aplicables.
  • Documenta resultados de defectos en las formas aplicables y en el sistema de Infinity QS.
  • Documentar por medios manuales (ej. Checker Chart) y/o sistema electrónico de POMS la información requerida por especificaciones y procedimientos aplicables.
  • Utilizar sistema electrónico (Xinco) y/o manual para la verificación de la documentación vigente.
  • Cumplir en todo momento con las Buenas Prácticas de Manufactura (GMP), Buenas Prácticas de Documentación (GDP) con las reglas de la compañía y règulaciones de EHS
  • Responsable de realizar inspecciones de EHS de forma continua para identificar y corregir peligros de seguridad y aspectos ambientales.
  • Seguir los procedimientos aplicables, y analizar los incidentes de EH (incluyendo las fallas cercanas) para encontrar las causas y tomar acciones correctivas.
  • Comunicar cualquier desviación en el proceso que impacte o pudiera impactar las métricas operacionales (OEE, Quality, Safety, entre otras).
     
Cualificaciones: 
  • Diploma de Escuela Secundaria. 
  • Dos (2) años o más de experiencia en manufactura y calidad. 
  • Conocimientos en lectura e interpretación en inglés. 
  • Conocimiento en TIQ y uso de equipo de medición
  • Conocimientos en GMP y GDP
  • Disponible para trabajar 3er turno. 

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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