Process Team QA

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.