Sr. Quality Assurance Associate - Investigation Coordinator

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:
Sr. Quality Assurance Associate
- Investigation Coordinator As the Sr. 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.

Your 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/6MEnsure 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

What You Need to Succeed (minimum qualifications):

Education:

Bachelor’s degree in a scientific discipline preferred

Experience:

​6+ years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)5+ years of experience with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M, etc.)Experience reviewing and approving GMP documentation, investigations, and CAPAsExperience with risk assessment tools and quality metrics reporting

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.

What Will Give You a Competitive Edge (preferred qualifications):

Strong technical writing and communication skills

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 with in animal health or pharmaceutical manufacturing environments

Additional Information:

Travel:
Occasional