Quality Assurance Release Specialist

Iowa Ag; Fort Dodge (IA); On-site; USD 60,000 - 85,000; Full time

Job summary

Elanco is seeking a Quality Associate to provide critical production support for the QA Release Group. You will review batch records and technical documentation to ensure regulatory compliance and support audits, while assisting with deviation management and CAPA activities.

The role offers on-site work in a GMP setting, with opportunities to contribute to product releases and continuous improvement initiatives within the Process Team.

Qualifications

• Bachelor's Degree in a scientific discipline; or a High School Diploma / GED with equivalent relevant experience.
• 1–2 years of experience in a GMP-regulated environment (pharmaceuticals or biologics).
• Experience reviewing GMP-regulated documents (batch records, SOPs, investigations).
• Proficiency with computer systems including Microsoft Suite, SAP, and Veeva.

Responsibilities

• Review and approve batch records and associated documentation for routine production, validation, and change control to ensure compliance with USDA, FDA, and EU regulations.
• Provide real-time, on-the-floor quality support for batch reviews, process auditing, and quality guidance to production personnel and the Process Team.
• Support deviation management by identifying non-conformances, determining root cause, and contributing to investigation reports.
• Assist with internal and external inspection audits by helping with preparation and response, and track continuous improvement goals.

Job description

Elanco is seeking a Quality Associate to provide critical production support for the QA Release Group. You will review batch records and technical documentation to ensure regulatory compliance and support audits, while assisting with deviation management and CAPA activities.

The role offers on-site work in a GMP setting, with opportunities to contribute to product releases and continuous improvement initiatives within the Process Team.