Quality Assurance Associate – Control Coordinator

Quality Assurance Associate – Change Control Coordinator

As the Quality Assurance Associate – Change Control Coordinator, you’ll partner cross‑functionally with Manufacturing, Process, Warehouse, Facilities, Quality Control and Quality Assurance to support and oversee the site change‑management process. You’ll drive change controls, investigations and quality systems activities toward timely closure while ensuring compliance with GMP and regulatory expectations.

• Coordinate and oversee daily activities within the site change‑management system.
• Lead or support Change Review Board 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.
• 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.

Minimum qualifications:

• 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 with the ability to independently manage cross‑functional quality initiatives in a GMP‑regulated environment.

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).
• Proficiency with 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, KS.
• This role primarily supports standard business operations but may require occasional work outside of normal business hours to meet operational or compliance needs.

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

Elanco is an EEO/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.