Senior QA Change Control Lead - Cross-Functional GMP

Elanco; Elwood (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus

Flexible work arrangements

6% 401K matching

Job summary

Elanco seeks a Sr. Quality Assurance Associate - Change Control Coordinator to oversee the site change management system, drive change controls to timely closure, and support investigations with root cause analysis.

The role partners across Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and QA to ensure GMP compliance. Ideal candidates have 8+ years in QA within regulated industries and 6+ years with change control and RCA tools.

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 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 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
• Participate in audits, inspection readiness activities, and continuous improvement initiatives
• Manage QA projects independently with minimal oversight
• Support a strong quality culture through coaching and collaboration

Skills

Change control

Root cause analysis

Cross-functional collaboration

GMP compliance

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

Microsoft Office

Job description

Elanco seeks a Sr. Quality Assurance Associate - Change Control Coordinator to oversee the site change management system, drive change controls to timely closure, and support investigations with root cause analysis.

The role partners across Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and QA to ensure GMP compliance. Ideal candidates have 8+ years in QA within regulated industries and 6+ years with change control and RCA tools.