Quality Engineer II – Investigations
US - Missouri - St. Louis Update time: July 30,2020
Job Description

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.

What will you do?

  • Assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.
  • Perform root cause analysis (RCA)
  • Facilitate cross functional teams to evaluate causal factors
  • Provide written documented investigations in an appropriate and timely manner.
  • Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues
  • 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

  • Bachelor degree in Science required, preferably in a scientific discipline.

Experience

  • Minimum of 1-3 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.
  • At least 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.
 

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.
 

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