Process QA SME: Manufacturing Quality & Compliance

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 70,000 - 90,000; Full time

Job summary

Elanco is seeking a Process Team QA Associate to provide quality oversight for manufacturing operations and maintain site quality systems. You will serve as the Quality SME for assigned streams, guiding investigations and ensuring GMP compliance.

Responsibilities include leading deviation investigations, managing quality records in Veeva, and collaborating with TSMS, Engineering, Production, and Quality Control to drive continuous improvement and Right First Time manufacturing.

Qualifications

• Associate or Bachelor's degree in a science-related field with relevant experience.
• Experience in pharmaceutical processes, vaccine manufacturing, or Quality Control.
• Strong analytical thinking and technical writing skills.

Responsibilities

• Lead deviation investigations, root cause analysis, CAPA development and change impact assessments.
• Manage quality records lifecycle in Veeva with proper documentation and timely closure.
• Review ESRs, PSRs, and RTS documentation for technical accuracy.
• Collaborate with TSMS, Engineering, Production, and QC to improve processes and Right First Time manufacturing.
• Support inspections, SOP development, and training to ensure readiness.

Skills

Analytical thinking

Technical writing

Problem solving

Education

Associate degree in science-related field

Bachelor's degree in science-related field

Tools

Veeva

SAP

Microsoft Office

Job description

Elanco is seeking a Process Team QA Associate to provide quality oversight for manufacturing operations and maintain site quality systems. You will serve as the Quality SME for assigned streams, guiding investigations and ensuring GMP compliance.

Responsibilities include leading deviation investigations, managing quality records in Veeva, and collaborating with TSMS, Engineering, Production, and Quality Control to drive continuous improvement and Right First Time manufacturing.