Quality Assurance Associate – Investigation Coordinator

Elanco•Elwood, KS

1d•Onsite

About The Position

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 – Investigation Coordinator As the Quality Assurance Associate – Investigation Coordinator, you’ll partner cross-functionally with Manufacturing, Warehouse, Facilities, Quality Control, and Quality Assurance teams to support and oversee the site deviation and investigation management processes. You’ll help drive investigations, root cause analysis, and corrective actions to timely closure while ensuring compliance with GMP and regulatory expectations. This role serves as a key partner in maintaining site quality standards, supporting continuous improvement initiatives, and strengthening operational compliance across the facility.

Requirements

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

Nice To Haves

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

Responsibilities

Coordinate 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 such as 5 Whys and Ishikawa/6M
Ensure appropriate 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