Root Cause Investigator Specialist
Elanco Tiergesundheit AG, Topeka, KS, United States
Root Cause Investigator Specialist page is loaded## Root Cause Investigator Specialistlocations:
Elwood, KStime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R0025370**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.**Your 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.**What You Need to Succeed (minimum qualifications):*** **Education:** Bachelor’s degree in a STEM-related field.* **Experience:** Minimum of 3 years of experience in a GMP-regulated environment, with at least 2 years leading or supporting root cause investigations.* **Top 2 Skills:** 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.**What will give you a competitive edge (preferred qualifications):*** 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.**Additional Information:*** Location: Elwood, Kansas* Travel: Occasional (
Elwood, KStime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R0025370**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.**Your 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.**What You Need to Succeed (minimum qualifications):*** **Education:** Bachelor’s degree in a STEM-related field.* **Experience:** Minimum of 3 years of experience in a GMP-regulated environment, with at least 2 years leading or supporting root cause investigations.* **Top 2 Skills:** 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.**What will give you a competitive edge (preferred qualifications):*** 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.**Additional Information:*** Location: Elwood, Kansas* Travel: Occasional (