Quality Associate-Quality Assurance

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Warszawa, Mazowieckie, POL
In-Office
Healthtech • Pharmaceutical • Manufacturing
The Role

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Position Description:

The Elanco Solution Center (ESC) Quality Associate supports the ESC Quality Manager in managing operational activities relating to the implementation, maintenance and operations of the Quality Management System for the Elanco Solution Center and providing an independent quality oversight on ESC GxP activities and decisions.

The ESC Quality Associate acts as a quality contact for ESC teams and as ESC quality contact for the Elanco Affiliates. Works closely with business partners in both the ESC, Affiliates and Affiliate QA organization to ensure quality activities are managed in an efficient manner and specific Affiliate requirements are met.

The ESC Quality Associate acts as Regional Quality Master Data Steward assuring that Affiliate Requests for Local Quality Objects are correctly managed in S4 HANA.

Functions, Duties, Tasks:

In the role of ESC QA Associate

  • Cooperate with other ESC Quality Associates and ESC Quality Manager to ensure that the Quality Management System is in place to assure that activities managed by ESC comply with the applicable local regulations, GxP requirements and other applicable Elanco quality standards.
  • Provides guidance and help to ESC departments on resolution of identified quality issues
  • Responsible for the completion & accuracy of ESC operational quality tasks, including but not limited to deviations management, change control management, quality document management and maintenance of the Quality Plan, Quality Agreements  
  • Involved in continuous improvement and risk mitigation, routine self-assessment, corrective and preventative actions (CAPA) and use of the Quality Plan
  • Support Audit preparations and observation completion
  • Raise Notifications to Management, if and when required
  • Participates in activities related to QA Affiliate organization including but not limited to document / process review optimization and harmonization, recall activities, inventory management (stock reconciliation etc.)
  • Monitor, trend, interpret & report on Quality metrics

 In the role of Regional Quality Master Data Steward:

  • Responsible for managing Local Quality Object Requests in SAP S4/HANA
  • Supports Affiliate QA organization (QM Power User/Super User), providing additional ad hoc trainings for QA S4/HANA users

Minimum Qualification (education, experience and/or training, required certifications):

Education:

Bachelor degree in pharmacy, science, engineering, or related field and / or relevant experience

Experience:

  • Fluent in English (written & verbal)
  • Experience with working in a GxP environment
  • Good knowledge of SAP (S4 HANA) – Quality Module and Quality Master Data Management
  • Good knowledge of standard MS Office tools
  • Effective organizational and planning skills
  • Good self-organization and independence
  • Effective communications (written/verbal) skills
  • Effective interpersonal skills, experience with cross-functional international cooperation
  • Demonstrated analytical & investigational skills with due attention to detail

Additional Preferences:

  • Knowledge of Quality processes (incl. but not limited to Batch Management, Recall activities, Product Complaint management, Customer License management)
  • Knowledge of O2C and Supply chain processes (i.e. Order Management, Return Management, and Inventory management – expiration, stock adjustment etc.)

Elanco is an EEO/Affirmative Action Employer and 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

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The Company
HQ: Greenfield, Indianna
8,445 Employees

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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