Root Cause Investigator Specialist

Elanco•Elwood, KS

5d•Onsite

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: Root Cause Investigator Specialist The Root Cause Investigator Specialist is responsible for leading and supporting root cause analysis and quality event management for monoclonal antibody (mAb) production at the Elwood, Kansas site. This role partners closely with cross-functional teams to drive thorough investigations, ensure high-quality documentation, and implement effective corrective and preventive actions (CAPA). The position plays a key role in strengthening compliance, improving processes, and fostering a culture of quality and continuous improvement.

Requirements

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; and the ability to collaborate cross-functionally while producing 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 (e.g., DMAIC, 5 Whys, 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 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 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 strong culture of safety, quality, and accountability.