Root Cause Investigator - Manufacturing

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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: Operations Associate – Root Cause Investigator

As the Root Cause investigator, you’ll support and lead the manufacturing organization in root cause analysis and quality event management for monoclonal antibody production.

In this role, you’ll partner with cross functional teams to lead and support quality event management through investigation, technical writing, continuous improvement, and mentorship to ensure compliance and robust corrective and preventative action.

Your Responsibilities:


* Lead root cause investigation for Quality and Safety event management


* Partner with and mentor cross-functional staff in investigation and technical writing skills


* Deliver technical documentation including summary reports, deviation and change management, procedures, and other manufacturing related documentation


* Lead process improvement kaizens and drive process analytics discussions related to manufacturing KPI


* Uphold strong safety and quality culture

What You Need to Succeed (minimum qualifications):


* Education: Bachelors Degree in STEM related field


* Experience: 3 years GMP experience with minimum of 2 years Root Cause Investigation


* Experience in root cause investigation

What will give you a competitive edge (preferred qualifications):


* Proven technical writing capability


* Six Sigma Green Belt or higher


* Formal Root Cause Problem Solving training


* Quality event management – Deviation, Change, CAPA etc


* Cross-functional team work


* Strong coaching/mentorship skills

Additional Information:


* Travel: occasional