Thermo Fisher Scientific QA Compliance Specialist II in Rockford, Illinois

Job Description

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?

Provide Quality Assurance Support to the Rockford 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?

  • Provide Quality Assurance Support to the Rockford site

  • Complete Customer surveys and specification verifications

  • Review and approve engineering change notices and deviations for appropriateness and to determine potential effect on product quality

  • Assist with the maintenance of ISO registration and the internal audit program

  • Investigate quality problems

  • 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 procedure

  • Review and update standard operating procedures

  • Create and revise quality policies and procedures

  • Collect and analyze quality data

  • 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?

Education

  • Bachelors degree required in a scientific discipline

Experience

  • Preferred 5+ years experience in a manufacturing or quality environment

Knowledge, Skills, Abilities

  • Knowledge of ISO and cGMP required

  • 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

  • Self-motivated with the ability to work as a team player and/or independently

  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

  • Normally receives no instruction on routine work and general instructions on new assignments

  • Obtains solutions through independent analysis, but consults supervisor prior to initiation

  • Customer focused

  • Experienced dealing with customers and suppliers

  • Experience as a trainer/coach

  • Ability to interact with other departments and communicate at a higher level is critical

  • Implement new programs/processes with little direction

  • Ability to effectively communicate requirements without alienating audience

At Thermo Fisher Scientific, each one of our 70,000 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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further 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.