Senior QA Investigator - Compliance & RCA Leader

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

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work

401K matching

Job summary

Elanco, a global leader in animal health, is seeking a Sr. Quality Assurance Specialist - Investigations & Compliance to partner with Manufacturing, Warehouse, Facilities, and Quality teams.

You will drive investigations, root cause analysis, and CAPAs to ensure timely closure and adherence to GMP and regulatory expectations. In this role, you will lead or support DRB activities, communicate status across departments, and mentor teams to strengthen site quality and continuous improvement.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 6+ years QA experience in a regulated industry.
• 5+ years investigating deviations and performing RCA.
• Experience reviewing GMP documents, investigations, and CAPAs.

Responsibilities

• Coordinate daily activities within the site deviation management system.
• Lead deviation investigations to timely, compliant closure.
• Facilitate or support Deviation Review Board (DRB) activities and cross-functional collaboration.
• Drive root cause analysis (RCA) 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 and quality reviews.
• Provide technical review and guidance for investigations and quality records.

Skills

Investigation

Root cause analysis

Cross-functional leadership

GMP manufacturing

Education

Bachelor's degree in science

Tools

eQMS

MS Office

Job description

Elanco, a global leader in animal health, is seeking a Sr. Quality Assurance Specialist - Investigations & Compliance to partner with Manufacturing, Warehouse, Facilities, and Quality teams.

You will drive investigations, root cause analysis, and CAPAs to ensure timely closure and adherence to GMP and regulatory expectations. In this role, you will lead or support DRB activities, communicate status across departments, and mentor teams to strengthen site quality and continuous improvement.