Senior Associate-Quality Assurance

About the role

As a Quality Assurance Associate – R&D Quality Assurance at Elanco, you will support the Research & Development Clinical Development organization by providing quality oversight for regulated animal health research and development activities.

Responsibilities

• Support execution of the site Quality Assurance program in compliance with FDA GLP regulations, USDA requirements, and Elanco Quality Standards Plan
• Conduct audits of regulated studies, systems, protocols, data, and final reports to ensure compliance with protocols, SOPs, and regulatory requirements
• Provide quality oversight for third-party GLP studies, including protocol and final report review activities
• Support deviations, investigations, CAPA activities, and process audits to strengthen quality systems and compliance
• Assist with regulatory inspection readiness, quality training, and ongoing Quality Management System support

Requirements

• Education: Bachelor’s degree in science, Animal Science, or related field
• Experience: Minimum 3 years’ experience working in a regulated (GCP, GLP) research environment
• Top 2 skills: Strong attention to detail and regulatory compliance mindset combined with effective communication and collaboration skills

Preferred qualifications

• Experience working in regulated environments such as FDA, USDA, or EPA
• Experience in research laboratories, veterinary studies, or livestock production settings
• Knowledge of Quality Systems and Computer System Validation processes
• Experience supporting audits, investigations, or CAPA activities
• Demonstrated learning agility and ability to work cross-functionally in a regulated environment

Benefits

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.