Junior Quality Assurance Inspector Packaging Operations

Main purpose and objective of the position:

Ensure that quality systems directly and indirectly related to Packaging processes are managed in accordance with established quality standards.

Key responsibilities:

• Review and/or approve GMP documentation: previous and packaging batch records, specifications, sequential area records. Important to know how to make decisions.

• Provide support to the packaging area for online issues, as well as sampling, performing in-process controls, and inspection of bulk and finished product.

• Collaborate in meeting the objectives related to deviations, changes, complaints, corrective or preventive actions.

• Ensure that reworks and reprocesses are carried out when authorized.

• Recommend and initiate quality improvements in Operational Areas and make recommendations to the Operations Quality Assurance Manager or any other Quality Unit manager/representative to take action on problems and/or improvements.

• Ensure communication of relevant quality issues to the Operations Quality Assurance Manager or, failing that, to another Quality Unit manager.

• Perform any activity within the quality area, provided that training has been received.

Academic requirements:

Higher Degree in Quality Analysis and Control.

Language requirements:

English recommended.

Work shift:

Day shift (7:00 AM - 7:00 PM) from Monday to Sunday, with corresponding weekly rest days set by the calendar.

full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

• Interpersonal skills: teamwork, customer orientation (internal/external), decision-making, good oral and written communication.

• Organizational skills: ability to prioritize objectives.

• Technical skills: knowledge of Good Manufacturing Practices, quality concepts, and their application in the pharmaceutical industry.

• Computer skills: knowledge of common office software at a user level, as well as knowledge of the computer systems that control business processes.

No prior experience required.

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.

#WeAreLilly

Propósito principal y objetivo del puesto:

Asegurar que los sistemas de calidad directa e indirectamente relacionados con los procesos de Empaquetado se gestionan de acuerdo con los estándares de calidad establecidos.

Responsabilidades clave:

• Revisión y/o aprobación de documentación GMP: previas y lotes de empaquetado, especificaciones, secuenciales del area. Importante saber tomar decisiones.

• Dar soporte al área empaquetado ante incidencias en línea así como la toma de muestras, la realización de controles en proceso y la inspección de granel y producto terminado.

• Colaborar en el cumplimiento de los objetivos de acciones relacionados con desviaciones, cambios, reclamaciones, medidas o acciones correctoras.

• Asegurar que los retrabajos y devoluciones se ejecutan adecuadamente cuando se tenga autorización para ello.

• Recomendar e iniciar mejoras de calidad en Areas Operativas y realizar recomendaciones al responsable de Garantía de Calidad Operaciones o a cualquier otro responsable/representante de la Unidad de Calidad para realizar acciones sobre problemas y/o mejoras.

• Asegurar la comunicación de problemas de calidad importantes al responsable de Garantía de Calidad Operaciones o en su defecto a otro responsable de la Unidad de Calidad.

• Realizar cualquier actividad dentro del area de calidad estando previamente entrenado.

Requerimientos de formación académica:

Grado Superior en Análisis y Control de Calidad.

Requerimientos de idiomas:

Inglés recomendado.

Turno de trabajo:

Turno diurno (7:00-19:00) de lunes a domingo, con sus correspondientes descansos semanales fijados por calendario.

full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

• Habilidades interpersonales: trabajo en equipo, orientación al cliente (interno/externo), toma de decisiones, buena comunicación oral y escrita.

• Habilidades organizativas: cualidades para priorizar objetivos.

• Habilidades técnicas: conocimiento en las normas de correcta fabricación, en conceptos de calidad y en su aplicación en la industria farmacéutica.

• Manejo de herramientas informáticas: conocimientos de software ofimático de uso común a nivel usuario, así como conocimiento de los sistemas informáticos que controlan los procesos de negocio.

Experiencia previa no requerida.

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.

#WeAreLilly