Thermo Fisher Scientific Quality Engineer II - Investigations in Saint Louis, Missouri
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?
- BS/ BA in biology, biochemistry, chemistry or other science related field is required.
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.
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
- 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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.