Quality Engineer/Scientist III

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Title: Quality Engineer/Scientist III
Requisition ID:
When you’re part of the team at ThermoFisher 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/Biologics Division
How will you make an impact?
The Quality Engineer/Scientist III will operate in a high-throughput environment, completing investigations on behalf of the various QC testing groups, but primarily for QC Analytical. This person is responsible for leading multiple investigations simultaneously and ensuring on-time completion through dedication, tenacity and relationship building with our partners in QA and the various testing groups. As a strong individual contributor, the Quality Engineer/Scientist III will maintain a high record closure rate while also working on the more complicated investigations. They will also assist more junior investigators when needed and will participate in QC compliance activities related to audits and continuous improvement.

What will you do?

• Conduct RAPID meetings with QA and QC staff
• Use TrackWise software to author investigations
• Be responsible for compliance-related deliverables including: audit support/observation response, presentations to senior management and site leadership, and generating trend reports to better understand the weaknesses in our organization and make suggestions for improvement
• Support compliance culture initiatives and assist manager and supervisor with implementing these changes.
• Develop the team through creation/delivery of proactive and reactive trainings.
• Assist with the development of tools and resources to improve our investigative process.
• Assist Scientist I and Scientist II investigators, and help remove roadblocks to record progression
• Average 1.5 deviation/OOS/CAPA record closures per week
• Complete overdue assessments and file record extensions as required
• Author/revise SOPs (limited)
• Assist with formulating continuous improvement strategies and timelines
• Other job duties as assigned

How will you get here?

• Minimum of an Associate’s degree
• Bachelor’s degree in science related field is a plus but not required
• 5 or more years working in a GMP regulated environment or Quality Role (QA or QC)
• 3 or more years as an investigation writer, CAPA developer, or auditor.
• TrackWise and TapRooT experience is preferred.

Knowledge, Skills, Abilities

• Knowledge of GMP regulations
• Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
• Able to read, write, and communicate in English.
• Able to use standard computer programs such as SmartSheet, PowerBI, MS Excel, Word, and PowerPoint.
• Able to inspire innovation and team effectiveness.
• Able to work in an evolving environment and adapt to a variety of internal customer’s needs
• Strong computer, scientific, and organizational skills.
• Strong communication skills including active listening, conflict resolution and the ability to effectively influence diverse team members for positive outcome.
• Enjoys collaborative efforts both internal and external to the department

Physical Requirements / Work Environment:
Wear gloves and other PPE to enter laboratory spaces
Sit for extended periods of time. This role requires a lot of desk time and meeting time.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, resolve difficult scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Disclaimer:
This job description presents the general content and requirements for the performance of this job. The description is not to be construed as an extensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to describe an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully abide by all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Thermo Fisher Scientific is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We strive to build an inclusionary work environment and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws

• Conduct RAPID meetings with QA and QC staff
• Use TrackWise software to author investigations
• Be responsible for compliance-related deliverables including: audit support/observation response, presentations to senior management and site leadership, and generating trend reports to better understand the weaknesses in our organization and make suggestions for improvement
• Support compliance culture initiatives and assist manager and supervisor with implementing these changes.
• Develop the team through creation/delivery of proactive and reactive trainings.
• Assist with the development of tools and resources to improve our investigative process.
• Assist Scientist I and Scientist II investigators, and help remove roadblocks to record progression
• Average 1.5 deviation/OOS/CAPA record closures per week
• Complete overdue assessments and file record extensions as required
• Author/revise SOPs (limited)
• Assist with formulating continuous improvement strategies and timelines
• Other job duties as assigne