Root Cause Investigator Specialist
Elanco
5 hours ago
On-site
Elwood, KS
Operations
Root Cause Investigator Specialist (mAb Production) — Elwood, Kansas
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.
Minimum Qualifications:
- Bachelor’s degree in a STEM-related field.
- Minimum 3 years’ experience in a GMP-regulated environment, including at least 2 years leading or supporting root cause investigations.
- Strong root cause investigation and problem-solving skills; ability to collaborate cross-functionally and produce clear, high-quality technical documentation.
- Strong understanding of quality systems, including deviations, CAPA, and change control processes.
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.
Benefits:
- Multiple relocation packages
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Up to 6% 401K matching
Additional Information:
- Occasional travel/off-hours support in a 24/7/365 manufacturing environment; standard business hours generally.
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.
Minimum Qualifications:
- Bachelor’s degree in a STEM-related field.
- Minimum 3 years’ experience in a GMP-regulated environment, including at least 2 years leading or supporting root cause investigations.
- Strong root cause investigation and problem-solving skills; ability to collaborate cross-functionally and produce clear, high-quality technical documentation.
- Strong understanding of quality systems, including deviations, CAPA, and change control processes.
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.
Benefits:
- Multiple relocation packages
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Up to 6% 401K matching
Additional Information:
- Occasional travel/off-hours support in a 24/7/365 manufacturing environment; standard business hours generally.