Associate-Quality Assurance-1

Elanco in; Fort Dodge (IA); On-site; USD 60,000 - 80,000; Full time

Job summary

Elanco is seeking an Associate-Quality Assurance-1 (Project Management) to provide critical QA support for the Release Group and Process Team in ensuring regulatory compliance and accurate documentation. You will review batch records and related technical files to enable product release while supporting audits and continuous improvement efforts.

The role emphasizes handling developmental, new, and revised records in alignment with USDA, FDA, and EU requirements to maintain high-quality animal

Qualifications

• Review and approve batch records and associated technical documentation for production, validation, and change control.
• Ensure compliance with USDA, FDA, and EU regulations.

Responsibilities

• Perform detailed review and approval of batch records and associated documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.
• Support audits and continuous improvement goals; assist with release of products that advance animal health.

Job description

Associate-Quality Assurance-1 (Project Management)

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: Quality Associate

As a Quality Associate, you will provide critical production support to the QA Release Group and Process Team. Your primary purpose is the review and approval of developmental, new, and revised product batch records and technical documentation (e.g., for validation, deviations, change control) to ensure compliance with all regulatory requirements (USDA, FDA, EU, etc.). You will serve as a key resource for projects, assist with audits, and support continuous improvement goals, playing a vital part in the release of products that advance animal health.

Your Responsibilities:

• Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.
• Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.;margin-top:5.0pt;