Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS)

Elanco • Elwood, KS

11d • Onsite

About The Position

The Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS) leads and supports root cause analysis and quality event management for monoclonal antibody (mAb) production at Elanco’s Elwood, Kansas site. The role partners with cross-functional teams to conduct thorough investigations, maintain high-quality documentation, and implement effective corrective and preventive actions (CAPA). It contributes to compliance, process improvement, and a culture of quality and continuous improvement. This is a fixed-term position that operates during standard business hours, with occasional off-hours support in a 24/7/365 manufacturing environment. Occasional travel of less than 10% is expected.

Requirements

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

Nice To Haves

• Experience in commercial monoclonal antibody or recombinant protein manufacturing.
• Demonstrated strength in technical writing and documentation.
• Six Sigma Green Belt or higher, or equivalent continuous improvement training.
• Formal training in root cause analysis methodologies such as DMAIC, 5 Whys, or Fishbone.
• Proven ability to collaborate across cross-functional teams, with strong coaching and communication skills.

Responsibilities

• Lead and facilitate root cause investigations for quality and safety events, ensuring timely, thorough, and compliant resolution.
• Collaborate with cross-functional teams and 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 standard operating procedures (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 culture of safety, quality, and accountability.

Benefits

• Comprehensive benefits package focused on financial, physical, and mental well-being.
• Multiple relocation packages.
• 8-week parental leave.
• 9 Employee Resource Groups.
• Annual bonus offering.
• Up to 6% 401(k) matching.

What This Job Offers

• Job Type: Full-time