Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Root Cause Analyst (Sterile Operations)R-01318767

Greenville, NC - site based role

How will you make an impact?

This position works at the departmental level and is responsible for determining true root cause for select operational issues and implementing effective Corrective Action Preventative Actions (CAPAs).

Support Greenville site with robust root cause identification, maintain quality aspects, develop solutions.

What will you do?

As a crucial member of the Technical Unit (TU), identify root causes and support the implementation of appropriate countermeasures. 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. Ensure 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.

How will you get here?

EducationA 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

Experience1-2 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.

EquivalencyEquivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, AbilitiesSolid 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.

At Thermo Fisher Scientific, each one of our 100,000+ outstanding minds has an unusual story to tell. Join us and contribute to our outstanding mission—enabling our customers to make the world healthier, cleaner, and safer. Apply today!