Senior QA Investigator: Deviation & RCA Lead (Flexible)

Elanco in; Elwood (KS); On-site; USD 89,000 - 109,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco is a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. This role supports site deviation management, investigations, CAPAs, and quality systems to ensure GMP compliance and continuous improvement.

The Sr. Quality Assurance Associate will partner with Manufacturing, Quality, and Facilities to drive investigation closure, root-cause analysis, and CAPA execution while maintaining a strong safety

Qualifications

• 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).
• Experience reviewing and approving GMP documentation, investigations, and CAPAs.

Responsibilities

• Coordinate and oversee daily activities within the site deviation management system.
• Lead and support deviation investigations to timely and compliant closure.
• Facilitate DRB activities and cross-functional collaboration.
• Drive root cause analysis using 5 Whys and Ishikawa/6M.
• Ensure 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 change controls, including impact assessments and quality reviews.
• Provide technical review and guidance for investigations, documentation, and quality records.
• Write, revise, and maintain QA procedures and controlled documents.
• Support site quality metrics related to deviations, investigations, and complaints.

Skills

Investigations & RCA

GMP Quality Assurance

Cross-functional collaboration

Quality metrics reporting

Education

Bachelor's degree in science

Tools

eQMS

MS Office

Job description

Elanco is a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. This role supports site deviation management, investigations, CAPAs, and quality systems to ensure GMP compliance and continuous improvement.

The Sr. Quality Assurance Associate will partner with Manufacturing, Quality, and Facilities to drive investigation closure, root-cause analysis, and CAPA execution while maintaining a strong safety