Root Cause Investigator – GMP Quality & CAPA

Elanco; Elwood (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus offering Up to 6%

401K matching

Job summary

Elanco in Elwood, Kansas seeks an Investigation Specialist - Technical Services / Manufacturing Sciences to lead root cause investigations and CAPA in monoclonal antibody production. You will collaborate across functions to ensure thorough documentation and compliant resolution.

Responsibilities include authoring investigation reports, deviations, change controls, SOPs, and supporting continuous improvement in a GMP environment. Relocation considered; travel occasional.

Qualifications

• Bachelor’s degree in a STEM-related field.
• Minimum of 3 years of experience in a GMP-regulated environment, with at least 2 years leading or supporting root cause investigations.
• Strong root cause investigation and problem-solving capabilities; ability to collaborate cross-functionally while producing clear, high-quality technical documentation.
• Understanding of quality systems, including deviations, CAPA, and change control processes.

Responsibilities

• Lead and facilitate root cause investigations for quality and safety events, ensuring timely, thorough, and compliant resolution.
• Collaborate with cross-functional teams to support and mentor staff on investigation methodologies and technical writing best practices.
• Author and review technical documentation including investigation reports, impact assessments, deviations, change controls, CAPAs, and SOPs.
• Drive continuous improvement initiatives through data analysis, Kaizen events, and KPI-driven discussions to enhance manufacturing performance.
• Perform risk and impact assessments to support decision-making and ensure regulatory compliance.
• Ensure adherence to GMP standards and internal quality systems while promoting a strong culture of safety, quality, and accountability.

Skills

Root cause investigation

Cross-functional collaboration

Technical writing

GMP quality systems

Education

Bachelor’s degree in STEM

Job description

Elanco in Elwood, Kansas seeks an Investigation Specialist - Technical Services / Manufacturing Sciences to lead root cause investigations and CAPA in monoclonal antibody production. You will collaborate across functions to ensure thorough documentation and compliant resolution.

Responsibilities include authoring investigation reports, deviations, change controls, SOPs, and supporting continuous improvement in a GMP environment. Relocation considered; travel occasional.