Senior QA Investigator: Deviation & RCA Lead

Elanco; Elwood (IN); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K match

Job summary

Elanco is seeking a Sr. Quality Assurance Associate - Investigation Coordinator to partner with Manufacturing, Quality and Facilities teams. You will oversee deviation management, drive investigations and CAPAs, and ensure GMP compliance while supporting continuous improvement across the site.

The role emphasizes root cause analysis and collaborative problem solving within a GMP-regulated manufacturing environment, requiring strong technical writing and quality metrics experience.

Qualifications

• Bachelor’s degree in a scientific discipline preferred
• 6+ years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)
• 5+ years of experience with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M, etc.)
• Experience reviewing GMP documentation, investigations, and CAPAs
• Experience with risk assessment tools and quality metrics reporting

Responsibilities

• Coordinate and oversee daily activities within the site deviation management system
• Lead and support deviation investigations to timely and compliant closure
• Facilitate or support Deviation Review Board (DRB) activities and cross-functional collaboration
• Drive and coach root cause analysis (RCA) activities using 5 Whys and Ishikawa/6M
• Ensure appropriate CAPAs are identified and implemented to reduce recurrence of deviations
• Communicate investigation status updates and timelines across departments
• Lead or assist customer complaint investigations as needed
• Support site quality metrics related to deviations, investigations, and complaint management
• Identify trends and support continuous improvement initiatives
• Promote a strong safety and quality culture through collaboration, mentorship, and technical coaching

Skills

Investigation

Root cause analysis

Cross-functional collaboration

GMP compliance

Education

Bachelor's degree in science

Tools

eQMS

Microsoft Office

Job description

Elanco is seeking a Sr. Quality Assurance Associate - Investigation Coordinator to partner with Manufacturing, Quality and Facilities teams. You will oversee deviation management, drive investigations and CAPAs, and ensure GMP compliance while supporting continuous improvement across the site.

The role emphasizes root cause analysis and collaborative problem solving within a GMP-regulated manufacturing environment, requiring strong technical writing and quality metrics experience.