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, making sure our food is safe and delivering COVID-19 solutions.
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: internal audit and 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?
Own the Eugene Site's internal audit program, responsible for schedule planning and adherence, auditor training, and timely resolution of resulting observations through root cause analysis and the application of effective corrective action
Support external audits (e.
g.
customer, corporate, notified body)
Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, and supplier questionnaires
Perform 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
Support the execution of the site's training program
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.
Auditing experience; ASQ CQA or ISO 13485 or 9001 Lead Auditor or Internal Auditor certifications preferred.
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.
Whatsapp
