Senior QA Change Control Lead – GMP/CAPA Expert

Elanco in; Elwood (KS); On-site; USD 112,000 - 137,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco in Elwood, KS is seeking a Sr. Quality Assurance Associate - Change Control Coordinator to oversee the site change management process and drive investigations, CAPA, and quality system activities.

The role partners with Manufacturing, Process Teams, Warehouse, Facilities, and QA to ensure GMP compliance and timely closure of change controls. The ideal candidate has extensive QA experience in regulated environments, strong root cause analysis skills, and the ability to lead

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

Cross-functional collaboration

MS Office

Education

Bachelor's degree in a scientific discipline

Tools

eQMS

MS Office

Job description

Elanco in Elwood, KS is seeking a Sr. Quality Assurance Associate - Change Control Coordinator to oversee the site change management process and drive investigations, CAPA, and quality system activities.

The role partners with Manufacturing, Process Teams, Warehouse, Facilities, and QA to ensure GMP compliance and timely closure of change controls. The ideal candidate has extensive QA experience in regulated environments, strong root cause analysis skills, and the ability to lead