Quality Assurance Associate: Batch Records & Compliance

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

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