Senior Quality Assurance Specialist

hace 3 semanas

Zapopan, Jalisco, México Elanco A tiempo completo
About Elanco

Elanco is a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision of 'Food and Companionship Enriching Life' drives our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise.

We foster a diverse and inclusive work environment where diversity is the driving force behind innovation, creativity, and overall business success. At Elanco, you'll be part of a dynamic team that values and champions new ways of thinking, working with individuals who share your passion for improving animal lives.

Quality Associate Role Overview

The Quality Associate will manage day-to-day activities relating to the implementation, maintenance, and operations of the Quality system for the Elanco Solutions Center. This role supports the Quality Manager ESC to provide independent quality oversight ESC GxP activities and decisions in collaboration with the Affiliate Quality organization to ensure specific Affiliate requirements are met.

The successful candidate will work closely with business partners in both the Affiliate organization and ESC to ensure Quality activities operate in an efficient manner.

Responsibilities
  • Work with the Quality Manager ESC to ensure that the Quality Systems in place to support activities managed through ESC comply with applicable GxP, other applicable company quality standards, and local regulations.
  • Support Quality Management activities within the ERP (SAP) system associated to Customers and Material Master (QM Power user & QM Data Steward activities).
  • Support Quality Management activities including but not limited to Recall activities, Product Complaint management, Customer License management, Inventory management (expiration, returns, adjustments).
  • Demonstrate continuous improvement and minimize risk by routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
  • Support Audit preparations and observation completion.
  • Raise Notifications to Management, if and when required.
  • Responsible for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, quality document management, and maintenance of the Quality Plan, Quality Agreements.
  • Monitor, trend, interpret & report on Quality metrics.
  • Help and give guidance on resolution of Quality issues.
  • Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.
Requirements

To succeed in this role, you should have:

  • Bachelor degree in pharmacy, science, engineering, or related field and/or relevant experience.
  • Previous experience working in a GxP environment.
  • Ability to work with others.
  • Attention to detail.
  • Effective communications (written/verbal) skills.
  • Experienced in both Microsoft Office and SAP.
  • Demonstrated analytical & investigational skills.
  • Effective organizational and planning skills.
  • Fluent in English (written & verbal).
  • Inventory management and QM data knowledge highly regarded.
Salary

The estimated salary range for this position is between $60,000 and $80,000 per year, depending on qualifications and location.

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