Investigation Lead - GMP Quality & CAPA (MS/TS)

Elanco; Kansas; On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Relocation package

8-week parental leave

Employee Resource Groups

Annual bonus offering

401K matching

Job summary

Elanco’s Investigation Specialist – Technical Services / Manufacturing Sciences role is based in Elwood, KS, focusing on leading root cause investigations for monoclonal antibody production and ensuring high-quality documentation and CAPA implementation. The position supports cross-functional teams and promotes compliance with GMP and quality systems.

The role emphasizes data-driven continuous improvement, risk assessment, and strong technical writing.

Qualifications

• Minimum 3 years in a GMP environment; at least 2 years leading or supporting root cause investigations.
• Strong root cause investigation and problem-solving capabilities.
• Ability to collaborate across cross-functional teams and produce clear, high-quality technical documentation.

Responsibilities

• Lead and facilitate root cause investigations for quality and safety events in a 24/7 manufacturing setting.
• Collaborate with cross-functional teams to mentor staff on investigation methodologies and technical writing.
• Author and review investigation reports, impact assessments, deviations, CAPAs, and SOPs.
• Drive continuous improvement through data analysis, Kaizen events, and KPI-based discussions to improve manufacturing performance.
• Perform risk and impact assessments to support decision-making and ensure regulatory compliance.
• Ensure adherence to GMP standards and internal quality systems, promoting a culture of safety and accountability.

Skills

Root cause analysis

Problem solving

Cross-functional collaboration

Technical writing

Education

Bachelor’s degree in STEM

Job description

Elanco’s Investigation Specialist – Technical Services / Manufacturing Sciences role is based in Elwood, KS, focusing on leading root cause investigations for monoclonal antibody production and ensuring high-quality documentation and CAPA implementation. The position supports cross-functional teams and promotes compliance with GMP and quality systems.

The role emphasizes data-driven continuous improvement, risk assessment, and strong technical writing.