Senior QA Change Control Lead — GMP & Cross-Functional

Farmer Veteran Coalition; Kansas; Híbrido; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

8-week parental leave

Annual bonus offering

Flexible work arrangements

6% 401K matching

Descripción de la vacante

Elanco is seeking a Sr. Quality Assurance Associate – Change Control Coordinator to collaborate across Manufacturing, Process Teams, QA, and Facilities to manage site change controls and ensure GMP compliance. You will drive investigations, CAPA, and QA documentation quality within a regulated manufacturing environment.

The role emphasizes strong cross-functional collaboration, change control execution, and continuous improvement to maintain site quality standards and operational excellence.

Formación

• 8+ years of Quality Assurance experience in 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.
• Strong ability to independently manage cross-functional quality initiatives in a GMP-regulated environment.

Responsabilidades

• 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.

Conocimientos

Change control

Root cause analysis

Educación

Bachelor's degree in a scientific discipline

Herramientas

eQMS

Microsoft Office

Descripción del empleo

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: Sr. Quality Assurance Associate – Change Control CoordinatorAs 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 systemLead or support Change Review Board (CRB) activities and facilitate cross-functional collaborationDrive change controls to closure in a timely and compliant mannerCommunicate status updates and timelines across departments to support operational alignmentSupport deviation investigations, including root cause analysis (RCA) and CAPA developmentProvide technical review and guidance for quality documentation, investigations, and change controlsWrite, revise, and maintain QA procedures and controlled documentsSupport site quality metrics related to change management and identify trends as applicableParticipate in audits, inspection readiness activities, and continuous improvement initiativesManage QA projects independently with minimal oversightSupport a strong quality culture through coaching, collaboration, and technical guidanceEducation: Bachelor's degree in a scientific discipline preferredWhat 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 controlsExperience with risk assessment tools and quality metrics reportingTop 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 skillsExperience with electronic Quality Management Systems (eQMS)Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint)Ability to manage multiple priorities with strong organizational skillsExperience working collaboratively across manufacturing and quality functionsStrong coaching and mentorship capabilitiesAdditional Information:Travel: Occasional Location: Elwood, KSThis role primarily supports standard business operations but may occasionally require support outside of normal business hours to meet operational or compliance needs.Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!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 packages8-week parental leave9 Employee Resource GroupsAnnual bonus offeringFlexible work arrangementsUp to 6% 401K matching#LI-HL#LI-OnsiteElanco 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.