Thermo Fisher Scientific Quality Assurance Specialist III in Fort Collins, Colorado
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.
How will you make an impact?
This position is located at our Fort Collins, CO which is home to our Cell Sorting Instrumentation center of excellence. We have an enthusiastic and high achieving team which is committed to providing scientists with cutting edge and high-quality instrumentation. We pride ourselves on delivering amazing results and value our unique culture. This individual will provide Quality Assurance Support to the Fort Collins site. Provide product and quality system information to internal and external customers. Review new paperwork and proposed changes for appropriateness and determine potential effects on product quality. Help strengthen our quality system and make improvements where needed. Help educate and promote adherence to Quality Assurance policies and requirements. Work with Quality Control in the review and development of specifications, test methods and protocols.
What will you do?
Complete specification verifications
Review and approve engineering change notices and deviations for appropriateness and to determine potential effect on product quality
Assist with the internal audit program
As needed, lead internal audits
Lead customer audits and answer questions as needed
Investigate quality problems
Perform and coordinate review of raw materials to determine continued suitability at retest/review dates
Assists with creation/modification of Certificates of Analysis templates
Assist Customer Service, Technical Support, Regulatory Affairs, and Analytical Services in addressing customer inquiries and concerns
Process product integrity customer complaints
Perform training on Quality procedures
Gather and maintain Country of Origin information
Review and update standard operating procedures
Perform and coordinate incoming inspection of purchased items as a back-up
Collect and analyze quality data
Ensure manufacturing equipment is calibrated as required
Participate, as needed, on new product teams
Perform all job duties in a safe manner and obeys all safety policies and procedures
Perform all job duties consistent with the Code of Ethics and the 4-I values
Perform all job duties within ISO standards, regulatory or statutory requirements
Perform other duties and cross training as assigned
How will you get here?
Bachelor's degree required.
7-10 years' experience in a quality role
Knowledge and direct experience working with ISO and/or cGMP regulations required
Experience working in a manufacturing environment, preferred.
Flow cytometry experience, a plus
Strong written and oral communication skills
Must be able to communicate effectively with multiple levels of staff throughout the organization
Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
Detail-oriented and accurate while maintaining a vision of the end result
Must be self-motivated with the ability to work as a team player and/or independently
Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of intangible factors
Obtains solutions through independent analysis with no direct supervision
Able to multi-task with no direction
Quality certification preferred
Provide guidance and training to more junior staff members
Strong risk management and crisis management skills
Exhibit strong presentation skills
Able to implement new programs/processes with little to no guidance
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.