Associate, Quality Assurance (Process Team)

Elanco•Fort Dodge, IA

3d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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