Senior QA Change Control Lead — GMP Compliance

Elanco Tiergesundheit AG; Elwood (KS); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

401K matching

Flexible work arrangements

Job summary

Elanco is seeking a Sr. Quality Assurance Associate - Change Control Coordinator to partner with Manufacturing, Process Teams, and Quality to manage site change controls in a GMP-regulated environment.

You will drive investigations, root cause analyses, and CAPA activities, ensuring timely closure and adherence to regulatory expectations while maintaining high-quality documentation and processes.

Qualifications

• 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

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

Skills

Change control

Root cause analysis

Quality metrics

Technical writing

Cross-functional collaboration

MS Office

Education

Bachelors in science

Job description

Elanco is seeking a Sr. Quality Assurance Associate - Change Control Coordinator to partner with Manufacturing, Process Teams, and Quality to manage site change controls in a GMP-regulated environment.

You will drive investigations, root cause analyses, and CAPA activities, ensuring timely closure and adherence to regulatory expectations while maintaining high-quality documentation and processes.