Your Role: Root Cause Investigator, Manufacturing OperationsAs the
Root Cause Investigator, Manufacturing Operations, 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
- Top 2 Skills: Experience in root cause investigation and hands on GMP experience
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
- Location: Elwood, KS
- The Elwood manufacturing facility is a 24/7/365 operation. This role has standard business hours and can anticipate occasional off-hour support needs.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
