Associate, Quality Assurance (Process Team)

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.

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!

Your Role: Associate, Quality Assurance (Process Team)

As a Quality Assurance Associate (Process Team), you will be part of Elanco Animal Health’s Quality organization, providing technical quality oversight across manufacturing and laboratory operations.

In this role, you will serve as a Quality Subject Matter Expert (SME), ensuring robust quality systems, supporting investigations, and partnering cross-functionally to drive compliant, risk-based, and efficient manufacturing processes.

Your Responsibilities:


* Serve as QA SME for assigned process areas, ensuring adherence to GMP standards and quality system requirements


* Lead and support deviation investigations, root cause analysis, and CAPA development to ensure effective and sustainable outcomes


* Manage and approve quality records (Deviations, Change Controls, CAPAs, Impact Assessments) within Veeva, ensuring timely closure


* Partner cross-functionally with TS/MS, Engineering, Production, and Quality Control to identify risks and drive Right First Time (RFT) improvements


* Support audit readiness and regulatory inspections, including SOP development, technical reviews, and quality governance activities

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree in a science-related field (e.g., Biology, Chemistry)


* Required Experience: Experience in pharmaceutical, vaccine manufacturing, or Quality Control environments with increasing technical responsibility (level dependent: P1–P3)


* Top 2 skills: Strong technical problem solving/critical thinking and ability to lead complex quality investigations and documentation

What will give you a competitive edge (preferred qualifications):


* Experience with Veeva, SAP, and Microsoft Office tools


* Prior experience in USDA/FDA regulated manufacturing environments


* Knowledge of Lean/Six Sigma methodologies


* Experience supporting regulatory inspections and audit readiness


* Strong technical writing and documentation skills

Additional Information:


* Travel: Minimal


* Location: Fort Dodge, IA Manufacturing Si...