Investigation Specialist – GMP Quality & Manufacturing Sciences

Kansas Ag Connection; Kansas; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

Employee Resource Groups

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco Investigation Specialist – Technical Services / Manufacturing Sciences is based in Elwood, Kansas, and leads root cause analyses for monoclonal antibody production with cross-functional teams. The role emphasizes rigorous documentation, CAPA, and compliance within GMP guidelines.

The position requires a STEM degree and at least 3 years in GMP environments, with preferred Six Sigma, DMAIC, or Fishbone training.

Qualifications

• Bachelor's degree in a STEM-related field.
• Minimum of 3 years in a GMP-regulated environment with root cause investigations.
• Strong writing skills for investigation reports, deviations, CAPA, and SOPs.

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.
• Author and review investigation reports, impact assessments, deviations, change controls, CAPAs, and SOPs.
• Drive continuous improvement through data analysis, Kaizen events, and KPI-driven discussions.
• Perform risk and impact assessments to support decision-making and regulatory compliance.
• Ensure adherence to GMP standards and internal quality systems while promoting safety and quality.

Skills

Root cause investigations

Problem solving

Cross-functional collaboration

Technical writing

Documentation

Quality systems

Education

Bachelor's degree in a STEM-related field

Job description

Elanco Investigation Specialist – Technical Services / Manufacturing Sciences is based in Elwood, Kansas, and leads root cause analyses for monoclonal antibody production with cross-functional teams. The role emphasizes rigorous documentation, CAPA, and compliance within GMP guidelines.

The position requires a STEM degree and at least 3 years in GMP environments, with preferred Six Sigma, DMAIC, or Fishbone training.