Job Title: Staff QC Engineer/Scientist
Requisition ID: 64286BR
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. 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, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
- Leads/participates in cross-functional and multi-site team projects (e.g. NPI, line transfers) ensuring that project deliverables comply with quality standards and regulations.
- Responsible for ensuring that design transfer activities are appropriately defined, executed and reported in support of effective transfers to manufacturing.
- Guides development and implementation of validation plans and master validation plans.
- Provides guidance in planning and execution of risk management activities and deliverables.
- Guides resolution of complex and critical problems, including identification of root cause, and ensures corrective/preventive actions are identified to ensure timely resolution of such problems
- Manages or supports Engineering Change Control process by reviewing Engineering Change Requests,
- Prepares clearly written business communications, investigation summaries, policies and procedures
- Supports RUO and GMP activities
- Participates in continuous improvement.
- Bachelor’s degree, preferably in biology, chemistry, biotechnology or related science. Master’s degree is a plus.
- Minimum 10 years related Quality Assurance experience working in ISO 9001, ISO 13485 and/or GMP environments.
- Experience leading risk management
- Experience with Design Control/Design Transfer/Design Changes and Process Validation/Analytical Method Validation
- Must demonstrate sound independent judgment and the ability to apply quality standards and regulations to operational processes and activities
- Must demonstrate effective leadership in guiding project teams to adopt practices consistent with ISO 13485 and GMP requirements, as applicable
- Strong computer skills (MS Office, Visio, Project); experience with SAP, Agile, TrackWise and database systems preferred.
- Must have effective communication skills and demonstrated ability to work collaboratively and cross-functionally
- Must demonstrate strong organizational skills and attention to detail.
- Must be able to acknowledge sense of urgency, adapt to organizational changes and work in a fast paced environment
Works primarily in an office environment, but also requires time in laboratory/manufacturing environments.
This position does not have relocation assistance
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.