Quality Assurance Associate – Control Coordinator – Elanco

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.

We pride ourselves on fostering a diverse and inclusive work environment, believing it drives innovation and business success. Joining us means working with dynamic individuals, acquiring new skills, and propelling careers to new heights. Making animals' lives better makes life better – join our team today.

Quality Assurance Associate – Change Control Coordinator

• 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

• Bachelor's degree in a scientific discipline (preferred)
• 8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)
• 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

• 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

• Travel:
  Occasional
• Location:
  
  Elwood, KST
• Hours may be outside normal business hours to meet compliance needs

• Multiple relocation packages
• 8‑week parental leave
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401(k) matching
• Employee Resource Groups

Elanco is an Equal Employment Opportunity/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills.

These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.