When you join Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and making sure our food is safe. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.
Location/Division Specific Information This role is based at our Eugene, Oregon campus, supporting our Biosciences Division. The Eugene Site maintains a ISO 13485 Quality Management System (QMS) certification, for manufacturing fluorescent dyes and reagents used for life sciences research.
How will you make an impact? The Quality Specialist I will report directly to the Quality Assurance Manager. The position's focus is to ensure the compliance and continual improvement of key QMS elements: Quality Systems compliance, document control, and training. This position also supports production partners as needed, to ensure on-time delivery to customers.
What will you do? Lead and manage change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners Lead and manage the execution of the site's training program Support internal & external audits (e.g. customer, corporate, notified body) Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing customer letters and other regulatory documents Maintain Quality records according to Thermo Fisher Scientific policies and procedures Support timely delivery of products to customers with lot release and preparation of certificates of analysis Other projects will be assigned as various business needs arise How will you get here? Education Associate's Degree; Quality Systems experience in a manufacturing environment may be considered in lieu of a degree. Experience Minimum of 1 year experience in the Quality Assurance function in an ISO 13485 or 9001 environment is required. Familiarity with the life sciences industry is desired. Familiarity with enterprise software systems including electronic document control systems, CAPA and training software packages Knowledge, Skills, Abilities Strong critical thinking skills, with a close attention to detail and history of good judgment Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfort learning and using new software programs Proven ability to work in a team and matrixed environment Driven and resourceful, with minimal to moderate direction required Proven ability to prioritize work according to urgency and impact, with good time management skills At Thermo Fisher Scientific, each one of our 80,000 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! 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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