Root Cause Analyst

About the role

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. This position works at the departmental level and is responsible for determining true root cause for select operational issues and implementing effective Corrective Action Preventive Actions (CAPAs). Support the Greenville site with robust root cause identification, maintain quality aspects, and develop solutions.

Responsibilities

• Identify root causes and support the implementation of appropriate countermeasures as a crucial member of the Technical Unit (TU).
• Work closely with operations and support teams.
• Apply the fundamentals of Root Cause Analysis, including 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, and Comparative Analysis.
• Provide root cause support for major investigations, including items from Production, Quality Control, Facilities, etc.
• Facilitate cross-functional teams to evaluate causal factors.
• Provide written detailed investigations in an appropriate and timely manner.
• Support the implementation of CAPAs that reduce or eliminate recurrence of issues, ensuring the CAPA addresses true root cause.
• Work independently, as well as collaborate with TU to get results, meet timelines, and improve processes.
• Effectively communicate with peers, colleagues, and site leadership regarding the status of root cause findings and recommendations.
• Provide technical experience and interpretation of data and results.
• Maintain a flexible schedule to meet the needs of the business.
• Other job duties as assigned.

Requirements

• BS/BA or equivalent experience in biology, biochemistry, engineering, or other science-related field is preferred, along with RCA leadership experience.
• Lean Six Sigma Green Belt or Black Belt preferred.
• 1-2 years of experience in the direct utilization of problem-solving tools (RCA tools including 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.
• Experience working in a regulated environment, preferably in biologics/pharmaceuticals.
• Exposure/Experience in Root Cause Analysis and/or LEAN/six sigma experience or PPI tools.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Skills

• Solid technical writing skills required.
• Solid communication skills.
• Knowledge of Microsoft Office Tools.
• Ability to drive functional, technical, and PPI.
• Ability to evaluate data and make recommendations based on data.
• Ability to make recommendations based on trends and trend analysis.
• Ability to work in a fast-paced environment with the ability to prioritize effectively to meet timelines.
• Facilitation skills for groups including staff-level employees.

Schedule

First Shift (Days)

Environmental Conditions

Office