Process Team QA

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

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Your Role

Process Team QA Associate As a Process Team QA Associate, you will provide technical quality oversight for manufacturing operations and maintain site quality systems. In this role, you will serve as the Quality Subject Matter Expert (SME) for assigned manufacturing or laboratory streams, providing technical guidance, quality governance, investigation support, and oversight to ensure robust quality outcomes and continued GMP compliance.

Your Responsibilities

• Lead and provide technical guidance for complex deviation investigations, root cause analysis, CAPA development, Change Impact Assessments, and other quality records.
• Own and manage the lifecycle of quality records within Veeva, ensuring technically sound documentation, appropriate prioritization, and timely closure.
• Perform technical and content reviews of Event Summary Reports (ESRs), Protocol Summary Reports (PSRs), and Return to Service (RTS) documentation.
• Partner with TSMS, Engineering, Production, and Quality Control to identify process risks, analyze quality metrics, and drive continuous improvement and Right First Time (RFT) manufacturing.
• Serve as a Quality SME during regulatory inspections and corporate audits while supporting SOP development, training, quality governance, and overall inspection readiness.

What You Need to Succeed (minimum qualifications)

• Education: Associate degree in a science-related field with relevant industry experience OR a Bachelor's Degree in a science-related field such as Biology or Chemistry.
• Experience: Demonstrated technical depth in pharmaceutical processes, vaccine manufacturing, or Quality Control, including experience with complex investigations and impact assessments.
• Skills: Advanced critical thinking and analytical problem-solving skills, along with strong technical writing skills.

What Will Give You a Competitive Edge (preferred qualifications)

• Experience with Veeva, SAP, and Microsoft Office.
• Prior experience in USDA and/or FDA-regulated manufacturing environments.
• Knowledge of Lean/Six Sigma methodologies.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.