Root-Cause Investigator, Tech Services & Quality

Elanco US; 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 is seeking an Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS) to lead and support root cause analyses for monoclonal antibody production. You will partner with cross-functional teams to drive thorough investigations and ensure high-quality documentation and CAPA implementation.

The role emphasizes GMP compliance, risk assessment, and continuous improvement through data analysis and SOP optimization.

Qualifications

• Bachelor's degree in a STEM-related field.
• Minimum of 3 years 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.

Responsibilities

• Lead and facilitate root cause investigations for quality and safety events.
• Collaborate with cross-functional teams to mentor staff on investigation methodologies and technical writing practices.
• Author and review technical documentation including investigation reports, impact assessments, deviations, 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

Education

Bachelor's degree in a STEM-related field

Job description

Elanco in Elwood, Kansas is seeking an Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS) to lead and support root cause analyses for monoclonal antibody production. You will partner with cross-functional teams to drive thorough investigations and ensure high-quality documentation and CAPA implementation.

The role emphasizes GMP compliance, risk assessment, and continuous improvement through data analysis and SOP optimization.