Job ID :
US – Utah – Logan
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.
– Involves review and approval of various product documentation such as labeling, specifications, and Certificates of Compliance
– Involves working with external suppliers for the purpose of setting up raw materials and ensuring proper compliance information is obtained.
– Perform duties in accordance with established company procedures and policies
– Develop, maintain and monitor programs for compliance with guidelines and standards applicable to Single Use products, including changes to guidance and standards
– Maintain a good understanding of AAMI, UPS, EP, ISO, and ASTM guidance and standards applicable to the business, and keeping abreast with changes and developments
– Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
– Review and interpret scientific literature and summarize effectively in writing.
– Identifies and routinely uses the most effective, cost-efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness
– Bachelor’s degree with majors in Science or Engineering
– 3 years of relevant working experience in a regulatory setting with knowledge in the pharmaceutical/medical/healthcare industry.
– Computer/software proficiency in Microsoft Windows, Microsoft Office, and Microsoft Outlook, or comparable systems, for the ability to prepare, edit, format and review documents to a high standard and to use in analysis, reports, and communication.
– Professional oral and written communications, interpersonal skills and problem-solving abilities.
– Good organizational skills and the ability to manage multiple tasks
– Ability to work independently Ability to lead teams
– Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
– A good attitude such as self-disciplined, self-motivated, active to take action and able to work under pressure
This position is not budgeted for relocation assistance.
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.
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