Process QA Lead — GMP Manufacturing & Quality SME

elanco; Iowa City (IA); On-site; USD 75,000 - 95,000; Full time

Job summary

Elanco is seeking a Process Team QA Associate to provide technical 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.

Collaborate with TSMS, Engineering, Production, and Quality Control to identify process risks, analyze quality metrics, and drive Right First Time manufacturing. You will support regulatory inspections, SOP development, and training.

Qualifications

• Education: Associate degree in a science-related field with relevant industry experience OR a Bachelor's Degree in a science-related field.
• Experience: Demonstrated technical depth in pharmaceutical processes, vaccine manufacturing, or Quality Control.
• Skills: Advanced critical thinking and analytical problem-solving skills, plus strong technical writing abilities.

Responsibilities

• Lead and provide technical guidance for complex deviation investigations, root cause analyses, CAPA development, Change Impact Assessments, and related quality records.
• Own and manage the lifecycle of quality records within Veeva, ensuring documented, prioritized, and timely closures.
• Perform technical reviews of ESRs, PSRs, and RTS documentation to ensure accuracy and compliance.
• Collaborate with TSMS, Engineering, Production, and Quality Control to identify process risks and drive continuous improvement and Right First Time manufacturing.
• Support regulatory inspections and audits, SOP development, training, and overall inspection readiness.

Skills

Analytical thinking

Technical writing

Investigations

CAPA experience

Education

Associate degree in science

Bachelor's degree in science

Tools

Veeva

SAP

Microsoft Office

Job description

Elanco is seeking a Process Team QA Associate to provide technical 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.

Collaborate with TSMS, Engineering, Production, and Quality Control to identify process risks, analyze quality metrics, and drive Right First Time manufacturing. You will support regulatory inspections, SOP development, and training.