Materials Compliance Specialist
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.
This role will provide resin materials expertise in the development of new products as well as work in collaboration with Engineering, Product Development and Quality to ensure products meet customer’s needs while maintaining compliance to regulation and performance in a wide variety of marketplaces. The Materials Specialist will be responsible for understanding various materials standards and product requirements, making material recommendations during new product development as well as product improvement opportunities. The Materials Specialist will understand raw materials compliance strategy and collaborate with Quality and Sourcing to proactively monitor and evaluate resins and materials used to meet current and anticipated customer needs globally for regulatory conformance.
- Understand and support overall raw materials compliance strategy
- Ensure our resins, colorants and other component materials meet current global/regional regulations and customer needs.
- Ensure raw material and product documentation is maintained for standard resins.
- Regulatory oversight on selected NPD/Sustainable Engineering projects.
- Material recommendations for NPD to meet new and evolving customer needs.
- Identify any potential testing and regulations applicable to the product application and the region of sale.
- Analyze test data in order to identify options and opportunities to improve the performance of the product.
- Assist in the follow-up of detailed materials/regulatory compliance queries from Manufacturing/Product Managers.
- Develop competency to support product and quality system compliance to FDA’s Quality System Regulation 21 CFR 820 and EN ISO 13485:2003.
- Supports Quality System assessments as required by the regulations and standards.
- Works in conjunction with Supplier Quality Engineer to identify resin supplier requirements and performance metrics.
- Work collaboratively with Sourcing team to identify new sources of resin as necessary.
- Work collaboratively with other facilities and other divisions as required.
- BS/BA - Chemistry (polymer science background/experience), Materials Science Degree or similar degree required
- A minimum of 3 years of experience within a regulated manufacturing industry preferred
- A minimum of 1 year of regulatory experience preferred (pharmaceutical, biologics or medical device, Industrial chemistry)
- Project management skills
- Experience working with cross-functional teams
- Technical writing experience, including document publishing skills
- Must be organized and detail oriented
- Ability to flexibly work on multiple parallel projects, pro-active, drive for improvement
- Hands-on experience with interpretation of domestic and international regulations and standards
- Strong oral communication skills
At Thermo Fisher Scientific, each one of our 50,000 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.
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.