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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.

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