Quality Assurance Associate – Investigation Coordinator

About the role

As a Quality Assurance Associate – Investigation Coordinator at Elanco, you'll play a crucial role in supporting and overseeing the site deviation and investigation management processes. This role involves coordinating daily activities, leading and supporting investigations, facilitating root cause analysis, and ensuring compliance with Good Manufacturing Practices (GMP) and regulatory expectations.

Responsibilities

• Cook up and oversee daily activities within the site deviation management system
• Lead and support deviation investigations to timely and compliant closure
• Facilitate or support Deviation Review Board (DRB) activities and cross-functional collaboration
• Drive and coach root cause analysis (RCA) activities using tools like 5 Whys and Ishikawa/6M
• Ensure appropriate Corrective and Preventive Actions (CAPAs) are identified and implemented to reduce recurrence of deviations
• Communicate investigation status updates and timelines across departments
• Lead or assist customer complaint investigations as needed
• Support site change controls, including impact assessments and quality reviews
• Provide technical review and guidance for investigations, documentation, and quality records
• Write, revise, and maintain QA procedures and controlled documents
• Support site quality metrics related to deviations, investigations, and complaint management
• Identify trends and support continuous improvement initiatives
• Promote a strong safety and quality culture through collaboration, mentorship, and technical coaching

Requirements

• Education: Bachelor’s degree in a scientific discipline preferred
• Experience: 6 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)
• Top 2 Skills: Strong investigation and root cause analysis expertise combined with the ability to independently manage cross-functional quality initiatives in a GMP-regulated manufacturing environment

Preferred Qualifications

• 5+ years of experience with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M, etc.)
• Experience reviewing and approving GMP documentation, investigations, and CAPAs
• Strong technical writing and communication skills
• Experience with risk assessment tools and quality metrics reporting
• Experience with electronic Quality Management Systems (eQMS)
• Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
• Ability to manage multiple priorities with strong organizational skills
• Experience working collaboratively across manufacturing and quality functions
• Strong coaching and mentorship capabilities
• Experience within animal health or pharmaceutical manufacturing environments