Quality Assurance Associate - Change Control Coordinator

Location: Elwood

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Quality Assurance Associate - Change Control Coordinator####

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** Quality Assurance
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** 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 - 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
** What You Need to Succeed (minimum qualifications):
*
* Education:

Bachelor's degree in a scientific discipline preferred

Experience:

8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)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):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
* 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
** Additional Information:
*** Travel:
Occasional

* Location:

Elwood, KS
* This role primarily supports standard business operations but may occasionally require support outside of normal business hours to meet operational or compliance needs.

Studies have shown under recognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a…