Root Cause Analysis Expert III at Thermo Fisher Scientific

| St. Louis, MO
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Job Description

RCA Expert III

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

This position works at the site level and is responsible for all aspects of executing major and critical deviations.

The Root Cause Analysis (RCA) Expert III is responsible for leading, facilitating and providing subject matter expertise as well as supporting St Louis site personnel with identification robust root causes to manufacturing deviations. Additionally, responsible for maintaining quality aspects of the RCA process, training and developing unique solutions that will help reduce reoccurring safety incidents. This role has a high level of visibility across the organization and provides feedback and solutions for risk reduction.

What will you do?

  • As a crucial member of the Root Cause Attack Team (RCAT), rapidly assess manufacturing deviations, identify root causes, and provide support in the implementation of appropriate countermeasures. Provide mentoring and coaching to supervisors and senior leadership.
  • Coach stakeholders and peers on the fundamentals of Root Cause Analysis to include 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe and Comparative Analysis.
  • Provide root cause support for major investigations including items originating from Production, Quality Control, Facilities, etc.
  • Facilitate cross functional teams to evaluate causal factors.
  • Provide written documented investigations in an appropriate and timely manner to assist Investigation Writers with required support.
  • Support the implementation of CAPAs that reduce or eliminate recurrence of issues. Ensures the CAPA addresses true root cause of the deviation.
  • Work with direct guidance and oversight to get results, meet timelines, and improve processes.
  • Effectively communicate with peers and colleagues regarding status of investigations and recommendations based upon investigation outcomes.
  • Provide technical experience and judgment as called upon during investigations and daily interpretation of data and results.
  • Other job duties as assigned.


How will you get here?

Education
  • BS/ BA in biology, biochemistry, chemistry or other science related field preferred or an appropriate level of RCA leadership experience.


Experience

  • 2-4 years of experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.
  • 3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals
  • Preferred experience in either upstream or downstream processing.
  • Exposure/Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operational Excellence 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.
  • Ability to drive functional, technical, and operational excellence.
  • 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 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

oyees.

Thermo Fisher Scientific

is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
More Information on Thermo Fisher Scientific
Thermo Fisher Scientific operates in the Biotech industry. The company is located in Waltham, MA. Thermo Fisher Scientific was founded in 2022. It has 61393 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 533 open jobs at Thermo Fisher Scientific, click here.
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