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Quality Assurance Associate – Change Control CoordinatorElanco • Elwood, New York, United States
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Quality Assurance Associate – Change Control Coordinator

Elanco
  • US
    Elwood, New York, United States
  • US
    Elwood, New York, United States
Jetzt Bewerben

Über

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):
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.
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.
Elanco Benefits and Perks:
Multiple relocation packages
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K 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. For more information on how we handle personal data, please see our Workforce Privacy Notice.
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  • Elwood, New York, United States

Sprachkenntnisse

  • English
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