Senior Associate-Quality Assurance

Responsibilities

• Support execution of the site Quality Assurance program in compliance with FDA GLP regulations, USDA requirements, and Elanco Quality Standards
• Plan and 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
• What You Need to Succeed (minimum qualifications):
• Education: Bachelor's degree in science, Animal Science, or related field
• Experience: Experience working around animals in a research, laboratory, or production environment
• Top 2 skills: Strong attention to detail and regulatory compliance mindset combined with effective communication and collaboration skills
• What will give you a competitive edge (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
• 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

Benefits

Additional Information

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: Quality Assurance Associate - R&D Quality Assurance As a Quality Assurance Associate - R&D Quality Assurance , you will support the Research & Development Clinical Development organization by providing quality oversight for regulated animal health research and development activities. In this role, you will help advance GLP compliance, quality systems oversight, and audit readiness while partnering cross-functionally to support global veterinary product approvals.

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