QA Specialist I
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com .
- Collect, analyze and present quality data.
- Establish and optimize test methods and product specifications..
- Analyze adequacy of inspection criteria and techniques, recognize critical attributes when establishing validation requirements.
- Develop and write protocols for new procedures.
- Review and edit existing procedures.
- Work with Product Development/Engineering to implement new processes and products.
- ECO Approvals
- PPI / Tier Board Coordinator/Communication
- CAPA and Customer Compliant Investigation and report writing follow up.
- Conduct Internal Audits
- Day to Day tasks as assigned
- Bachelor's degree preferred or relevant work experience.
- Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
- Ability to understand various manufacturing processes.
- Excellent writing and communication skills.
- Ability to interface well with others working at all levels.
- Ability to develop and implement procedures.
- Ability to perform investigative process as well as critical thinking and problem solving.
- Knowledge of statistical based computer programs such as Minitab, as well as Microsoft Office.
- Ability to read and understand CAD drawings.
- 1+ years of quality or engineering experience.
- Ability to understand various manufacturing processes including plastics manufacturing.
- Excellent technical skills.
- Ability to travel both domestic and some foreign.
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.