Root Cause Investigator Specialist

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Root Cause Investigator Specialist  ####

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** 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…