Quality Engineer II- Investigations

Job description

Deviation Investigator II

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 / Drug Substance

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.
• Optimally connect 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.
• Perform work with less oversight and seek more difficult deviations
• Other job duties as assigned.

How will you get here?

Education

• Bachelor's degree in science required, preferably in a scientific subject area.

Experience

• Minimum of 1-3 years of proven experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, TapRooT, Fishbone/6M, Kepnor-Tregoe, Comparative Analysis, etc.) with proven success.
• At least 1-2 years of demonstrated experience working in a regulated environment, preferably in biologics/pharmaceuticals.
• Or combination of above with college experience.

• Preferred experience in either upstream or downstream processing.
• Exposure/Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools.

Equivalency:

• Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills, Abilities

• Solid technical writing skills required.
• Solid communication and interpersonal 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 outstanding 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!

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.