Quality Assurance Associate – Change Control Coordinator

Elanco•Elwood, KS

2d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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