Documentation Specialist
Kelly Services
Job Description
Job Description
En Kelly®, estamos buscando un/a Documentation Specialist para un cliente en la industria farmacéutica en Puerto Rico. Si tienes experiencia en control de documentación y deseas formar parte de un ambiente regulado y dinámico, esta es tu oportunidad.
Detalles de la Posición:
- Posición: Documentation Specialist
- Turno: 10:30 AM – 7:00 PM
- Adiestramiento: 1er turno
- Disponibilidad: Debe estar disponible para trabajar horas extra (OT) y fines de semana según las necesidades del negocio.
- Mínimo 3 años de experiencia trabajando en control de documentación, QA Documentation o un área relacionada.
- Grado Asociado (AS) en Ciencias Secretariales, Administración de Empresas, Ciencias Naturales o área relacionada.
- Alternativamente, diploma de Escuela Superior o GED con 5 años de experiencia en control de documentación.
- Experiencia trabajando en un área de documentación dentro de un ambiente regulado.
- Alta destreza en Microsoft Word.
- Experiencia en preparación y revisión de documentación y/o batch preparation.
- Dominio de inglés y español, preferible.
Detalles de la Posición:
- Posición: Documentation Specialist
- Turno: 10:30 AM – 7:00 PM
- Adiestramiento: 1er turno
- Disponibilidad: Debe estar disponible para trabajar horas extra (OT) y fines de semana según las necesidades del negocio.
- Mínimo 3 años de experiencia trabajando en control de documentación, QA Documentation o un área relacionada.
- Grado Asociado (AS) en Ciencias Secretariales, Administración de Empresas, Ciencias Naturales o área relacionada.
- Alternativamente, diploma de Escuela Superior o GED con 5 años de experiencia en control de documentación.
- Experiencia trabajando en un área de documentación dentro de un ambiente regulado.
- Alta destreza en Microsoft Word.
- Experiencia en preparación y revisión de documentación y/o batch preparation.
- Dominio de inglés y español, preferible.
- Experiencia con sistemas de documentación.
- Conocimiento de Word y Excel.
- Conocimiento de SAP, LIMS, MES/POMS y/o Delta V.
- Experiencia en proofreading y revisión de documentos.
- Experiencia trabajando con procesos de cambio y aprobación de documentos.
- Experiencia en áreas de retención de documentos.
- Conocimiento de AttachePro, preferible.
- Experiencia en ambientes farmacéuticos o regulados, preferible.
- Procesar a través del Sistema de Documentación los documentos que llegan al área.
- Añadir y revisar las propiedades de los documentos.
- Aprobar documentos y sus propiedades en el sistema de documentación y liberarlos para distribución.
- Circular paquetes de manejo de cambios para revisión y aprobación, monitoreando las respuestas y asegurando las aprobaciones necesarias.
- Verificar el impacto de cambios a procedimientos sobre sistemas operacionales como SAP, LIMS, MES/POMS y Delta V.
- Verificar la sincronización de cambios entre los sistemas operacionales y el sistema de documentación.
- Coordinar cambios entre documentos compartidos por las plantas de Worcester, ABL y Singapore.
- Realizar proofreading de documentos que llegan al área de documentación.
- Preparar y revisar los PCR's manuales para las áreas de SVP (Small Volume Parenteral) y BDS (Bulk Drug Substance).
- Manejar el cuarto de retención y coordinar la transferencia de documentos a Iron Mountain.
- Recibir, evaluar y asignar fechas de efectividad a los documentos.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.Vacancy posted 2 days ago
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