Senior Associate-Quality Assurance

Quality Assurance Associate – R&D 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

Minimum qualifications:
- Bachelor’s degree in science, Animal Science, or related field
- Experience working around animals in a research, laboratory, or production environment
- Strong attention to detail and a regulatory compliance mindset, with effective communication and collaboration skills

Preferred qualifications:
- Experience 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