Quality SME – Process Manufacturing QA Champion

Iowa Ag; Fort Dodge (IA); Hybrid; USD 65,000 - 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 risks, analyze metrics, and drive Right First Time manufacturing. Prior experience in pharma processes and strong writing skills are essential.

Qualifications

• Minimum qualifications include an Associate degree in a science-related field or a Bachelor's Degree in Biology, Chemistry, or related field.
• Experience with pharmaceutical processes, vaccine manufacturing, or Quality Control, including investigations and impact assessments.
• Strong critical thinking, analytical problem-solving, and technical writing skills.

Responsibilities

• Lead investigations, root cause analysis, CAPA development, and change impact assessments.
• Manage quality records lifecycle in Veeva with proper prioritization and timely closure.
• Review Event Summary Reports (ESRs), Protocol Summary Reports (PSRs), and Return to Service documentation.
• Collaborate with TSMS, Engineering, Production, and Quality Control to identify process risks and drive continuous improvement and Right First Time manufacturing.
• Support SOP development, training, quality governance, and inspection readiness during regulatory audits.

Skills

Critical thinking

Analytical problem-solving

Technical writing

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 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 risks, analyze metrics, and drive Right First Time manufacturing. Prior experience in pharma processes and strong writing skills are essential.