Biotech Network Advisor, Quality Assurance  

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.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

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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!

Job Posting: Biotech Network Advisor, Quality Assurance  

Position Description: 

The Quality Assurance Advisor reports directly to the Quality Executive Director and supports the Biotech Network Sites for capital project activities and supplier quality.

This position will be responsible for supporting the design, engineering, commissioning, and qualification of facilities, utilities, and equipment.

The role ensures compliance with the requirements of all relevant regulatory agencies.

You will be responsible for advising and assisting in the review of commissioning, qualification, and validation documents supporting capital project execution.

The Quality Assurance Advisor will provide leadership and guidance to other Quality staff engaged in capital project and technology transfer activities, and support establishment/continual improvement of local business processes and procedures that align with Elanco operational standards across the Biotech Network.  The role will also provide support to all sites in the network related to materials management and the supplier quality program.  

Your Responsibilities: 


* Act as the Quality Assurance representative in all local and major capital project activities within the Biotech Network. 



* Participate in design, development, execution, commissioning, qualification, and validation activities for major projects.

This includes, but is not limited to: definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, and support for process validation. 



* Assist in defining needs for Quality Control testing laboratories and compliance needs of the same. 



* Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and influence/align with local and global business partners to ensure compliant delivery. 



* Act as a QA subject matter expert in project teams and committees...