Quality Control Laboratory Technician/Jr

The equipment technician position in the Quality Control laboratories is a technical support and/or collaboration position in tasks related to Quality Control equipment to meet the main objectives of the Alcobendas plant regarding:

• Ensuring the availability of equipment in adequate conditions to perform Quality Control analyses.

• Planning and performing the calibration, preventive, and corrective maintenance of laboratory equipment.

• Collaborating in the resolution of laboratory system incidents.

• Participating in the creation of instrumental methods for the equipment

• Managing and performing the qualification/validation of equipment included in the master validation plan within established deadlines, ensuring and making visible an adequate project plan with the involved areas.

• Evaluating the characteristics of equipment available on the market against requirements and coordinating the purchase of new equipment.

• Actively collaborating to ensure that the laboratory quality system is maintained in accordance with established quality standards.

• Identifying those incidents that must be managed as a deviation and carrying out the investigation thereof, identifying root causes and the necessary actions to prevent recurrence.

• Preparing and/or reviewing change controls related to laboratory equipment.

• Implementing and controlling the contracting of third parties for equipment maintenance. Performing periodic evaluations of contracted suppliers within the required timeframes.

• Evaluating changes in the various pharmacopeias that apply to equipment and systems and identifying and implementing the actions necessary to ensure compliance.

• Ensuring compliance with safety regulations and performing tasks related to their job position safely, complying with all health and safety requirements (appropriate clothing for their job position, wearing the necessary personal protective equipment for each task, etc.)

• Identify and communicate any situation that may pose a risk to people.

• Ensuring they are trained in all tasks assigned to them.

• Ensuring the maintenance/calibration of laboratory equipment by managing through adequate planning and anticipation of deadlines, documenting and closing the work orders associated with them in the required times.

• Providing experience and support to users on matters related to laboratory equipment and/or systems.

• Preparing technical documentation related to their job functions.

• Performing verifications and second-person reviews for other team members or tasks that so require.

• Problem solving, assessing equipment breakage or failures and starting repairs according to requirements. Evaluating the possible impact on quality in these cases. Evaluating the possibility of taking preventive actions to avoid the recurrence of such breakages or failures in the future.

• Controlling equipment repairs, maintenance, and budgets, as well as ordering and maintaining the stock of spare parts and laboratory consumables.

• Preparing and/or reviewing technical documentation required by their job position (e.g., procedures, work instructions, protocols...) based on their learning and experience.

• Ensuring the communication of quality problems to their supervisor.

• Recognizing when a deviation occurs and initiating, participating and/or performing a root cause investigation and identifying actions to prevent recurrence. Participating in laboratory analytical investigations when required.

• Preparing and/or reviewing change controls related to laboratory equipment.

• Dealing effectively and efficiently with customers, suppliers, and internal and external contacts.

• Managing and coordinating the installation and qualification/validation of new laboratory equipment based on learning and experience, as well as the associated documentation, in accordance with procedures and cGMPs.

• Participating in the adaptation and implementation of data integrity requirements in the laboratory.

• Implementing and controlling the contracting of third parties for equipment maintenance. Performing evaluations of contracted suppliers within the required timeframes.

• Training and guiding in the technical training of Quality Control equipment. Developing training material.

• Collaborating in the annual laboratory evaluation (MR).

• Collaborating in audits and self-inspections, preparing the area and documentation, as well as defending topics before auditors.

• Collaborating in compliance with the quality plan.

• Evaluating changes in the various pharmacopeias that apply to equipment and identifying and implementing the actions necessary to ensure compliance.

• Participating in and proposing Continuous Improvement initiatives within the group and related to their job position and collaborating in their implementation. Collaborating in the improvement of quality systems through the creation and review of documentation.

• Participate in behavior observations and in company initiatives to identify potential risks.

• Actively participating in inspection readiness walks, identifying actions that ensure the area is in perfect inspection condition.

Flexible

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

€26,170 - €38,390

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

• Interpersonal skills: Teamwork, customer orientation (internal/external), initiative and decision-making, good oral and written communication, listening skills, problem-solving ability.

• Organizational skills: Qualities to organize their workplace and daily activities in order to guarantee maximum quality. Ensuring a safe environment to avoid incidents and/or accidents. Attention to detail. Ability to work on several topics at once and prioritize objectives, as well as the escalation of incidents and potential delays.

• Technical skills: Knowledge of Good Manufacturing Practices, GMP policies and procedures. Ability to work in a highly regulated environment and apply technical judgment.

• Knowledge of Office Software at a user level, as well as knowledge of the computer systems that control the activities performed daily

La posición del técnico de equipos en los laboratorios de Control de Calidad es una posición de soporte técnico y/o colaboración en las tareas relacionadas con los equipos de Control de Calidad para cumplir con los objetivos principales de la planta de Alcobendas relativos a:

• Asegurar la disponibilidad de los equipos en adecuadas condiciones para realizar los análisis de control de Calidad.

• Planificar y realizar la calibración, mantenimientos preventivos y correctivos de los equipos del laboratorio.

• Colaborar en la resolución de incidencias de sistemas del laboratorio.

• Participar en la creación de métodos instrumentales de los equipos

• Gestionar y realizar la cualificación/validación de los equipos incluidos en el plan maestro de validación cumpliendo con los plazos establecidos, asegurando y visibilizando un adecuado plan de proyecto con las áreas involucradas.

• Evaluar las características de los equipos disponibles en el mercado frente a los requerimientos y coordinar la compra de nuevos equipos.

• Colaborar activamente en que el sistema de calidad del laboratorio se mantiene de acuerdo con los estándares de calidad establecidos.

• Identificar aquellas incidencias que deban ser gestionadas como una desviación y llevar a cabo la investigación de esta, identificando las causas raíces y las acciones necesarias para evitar la recurrencia.

• Elaborar y/o revisar controles de cambios relacionados con los equipos del laboratorio.

• Poner en marcha y controlar la contratación de terceros para el mantenimiento de equipos. Realizar las evaluaciones periódicas de los proveedores contratados en los plazos requeridos.

• Evaluar los cambios de las distintas farmacopeas que apliquen a equipos y sistemas e identificar e implementar las acciones que sean necesarias para asegurar el cumplimiento.

• Asegurarse que cumple las normas de seguridad y realiza las tareas relacionadas con su puesto de trabajo de forma segura, cumpliendo todos los requerimientos de seguridad e higiene (vestimenta apropiada a su puesto de trabajo, llevando los equipos de protección individual necesarios para cada tarea, etc)

• Identificar y comunicar cualquier situación que pueda suponer un riesgo para las personas.

• Asegurar que está entrenado en todas las tareas que le han sido asignadas.

• Asegurar el mantenimiento/calibración de equipos del laboratorio gestionando mediante una adecuada planificación y anticipación a los plazos, documentando y cerrando las órdenes de trabajo asociadas a los mismos en los tiempos requeridos.

• Aportar experiencia y apoyo a los usuarios en asuntos relacionados con los equipos y/o sistemas del laboratorio.

• Elaborar documentación técnica relacionada con sus funciones de trabajo.

• Realizar verificaciones y revisiones de segunda persona para otros miembros del equipo o tareas que así lo requieran.

• Resolución de problemas, valorar la rotura o fallos en los equipos y comenzar la reparación según los requerimientos. Evaluar el posible impacto en calidad en estos casos. Evaluar la posibilidad de tomar acciones preventivas para evitar la recurrencia de dichas roturas o fallos en el futuro.

• Controlar las reparaciones, mantenimientos y presupuestos de equipos, así como ordenar y mantener el stock de las piezas de repuesto y consumibles del laboratorio.

• Elaborar y/o revisar la documentación técnica requerida por su puesto de trabajo (ej., procedimientos, instrucciones de trabajo, protocolos...) en función de su aprendizaje y experiencia.

• Asegurar la comunicación de problemas de calidad a su supervisor.

• Reconocer cuando tiene lugar una desviación e iniciar, participar y/o realizar una investigación de causa raíz e identificar acciones para evitar la recurrencia Participar en las investigaciones analíticas del laboratorio cuando se requiera.

• Elaborar y/o revisar controles de cambios relacionados con los equipos del laboratorio.

• Tratar eficaz y eficientemente con clientes, proveedores y contactos internos y externos.

• Gestionar y coordinar la instalación y cualificación/validación de nuevos equipos del laboratorio en función de aprendizaje y experiencia, así como la documentación asociada, de acuerdo con los procedimientos y las cGMPs.

• Participar en la adecuación e implementación de los requerimientos de integridad de datos en el laboratorio.

• Poner en marcha y controlar la contratación de terceros para el mantenimiento de equipos. Realizar las evaluaciones de los proveedores contratados en los plazos requeridos.

• Entrenar y guiar en el entrenamiento técnico de los equipos de Control de Calidad. Desarrollar material de entrenamiento.

• Colaborar en evaluación anual del laboratorio (MR).

• Colaborar en las auditorías y autoinspecciones, preparando el área y la documentación, así como defendiendo los temas ante los auditores.

• Colaborar en el cumplimiento del plan de calidad.

• Evaluar los cambios de las distintas farmacopeas que apliquen a equipos e identificar e implementar las acciones que sean necesarias para asegurar el cumplimiento.

• Participar y proponer iniciativas de Mejora Continua dentro del grupo y relacionadas con su puesto de trabajo y colaborar en la implementación. Colaborar en la mejora de los sistemas de calidad mediante la creación y revisión de documentación.

• Participar en las observaciones del comportamiento y en las iniciativas de la compañía para identificar posibles riesgos.

• Participar activamente en los paseos de inspection readiness, identificando acciones que aseguren que el área se encuentra en perfecto estado de inspección.

Flexible

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

€26,170 - €38,390

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

• Habilidades interpersonales: Trabajo en equipo, orientación al cliente (interno/externo), iniciativa y toma de decisiones, buena comunicación oral y escrita, saber escuchar, capacidad para resolución de problemas.

• Habilidades organizativas: Cualidades para organizar su lugar de trabajo y sus actividades diarias con el fin de garantizar la máxima calidad. Asegurar un ambiente seguro para evitar incidentes y/o accidentes. Atención al detalle. Capacidad para trabajar con varios temas a la vez y priorizar objetivos, así como el escalado de incidencias y potenciales retrasos.

• Habilidades técnicas: Conocimiento en las normas de correcta fabricación, políticas y procedimientos GMP. Capacidad para trabajar en un ambiente altamente regulado y aplicar criterio técnico.

• Conocimientos de Software Ofimático a nivel de usuario, así como conocimiento de los sistemas informáticos que controlan las actividades que ejecuta diariamente