Sr. Quality Assurance Associate - Control Coordinator

Position: Sr. Quality Assurance Associate - Change Control 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
- Change Control Coordinator As the Quality Assurance Associate
- Change Control Coordinator, you’ll partner cross-functionally with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance to support and oversee the site change management process. You’ll help drive change controls, investigations, and quality systems activities to timely closure while ensuring compliance with GMP and regulatory expectations. This role serves as a key partner in maintaining site quality standards, improving processes, and supporting operational excellence across the facility.

Your Responsibilities:

Coordinate and oversee daily activities within the site change management system

Lead or support Change Review Board (CRB) activities and facilitate cross-functional collaboration

Drive change controls to closure in a timely and compliant manner

Communicate status updates and timelines across departments to support operational alignment

Support deviation investigations, including root cause analysis (RCA) and CAPA development

Provide technical review and guidance for quality documentation, investigations, and change controls

Write, revise, and maintain QA procedures and controlled documents

Support site quality metrics related to change management and identify trends as applicable

Participate in audits, inspection readiness activities, and continuous improvement initiatives

Manage QA projects independently with minimal oversight

Support a strong quality culture through coaching, collaboration, and technical guidance

Education:

Bachelor’s degree in a scientific discipline preferred

What You Need to Succeed (minimum qualifications):8+ years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)6+ years of experience with change control systems and RCA tools (5 Whys, Ishikawa/6M, etc.)Experience reviewing and approving GMP documentation, investigations, and change controls

Experience with risk assessment tools and quality metrics reporting

Top 2

Skills:

Strong expertise in change control and root cause analysis combined with the ability to independently manage cross-functional quality initiatives in a GMP-regulated 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

Additional Information:

Travel:
Occasional