Quality Assurance Consultant, Change Control

Elanco in; Elwood (KS); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401(k) matching

Job summary

Elanco in Elwood, KS is seeking a Quality Assurance Consultant, Change Control Coordinator to partner with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance. You will drive change controls, investigations, and QA systems activities while ensuring GMP compliance and timely closure across the site.

Responsibilities include leading CRB activities, overseeing daily change management, coaching teams, and contributing to continuous improvement initiatives.

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.

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.

Skills

Change control

Root cause analysis

Quality documentation

MS Office

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

Job description

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 Consultant, Change Control As the Quality Assurance Consultant, 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 <10% 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.

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching
• #LI-HL
• #LI-Onsite

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. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet.

Learn more at www.elanco.com.