Root Cause Analyst (Sterile Operations)
Root Cause Analyst (Sterile Operations)
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Root Cause Analyst (Sterile Operations)
R-
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
Education
- A 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
Experience
- 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.
Equivalency
- Equivalent combinations of education training and relevant work experience may be considered.
Knowledge Skills Abilities
- 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.
At Thermo Fisher Scientific each one of our 100000 outstanding minds has an unusual story to tell. Join us and contribute to our outstanding missionenabling our customers to make the world healthier cleaner and safer. Apply today!
Required Experience:
IC
Employment Type
Full-Time
