Thermo Fisher Scientific QA Specialist I in Rockford, Illinois

Job Description

About Thermo Fisher Scientific :

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. 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.

Position Summary:

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.

Key Responsibilities:

  • 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

  • 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 and animal 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

  • 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

Minimum Requirements/Qualifications:

  • Bachelors degree required in a scientific discipline

  • 2 years related experience in a manufacturing or quality environment

  • 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

  • Employee must be self-motivated with the ability to work as a team player and/or independently

  • Knowledge of ISO and cGMP requirements preferred

  • Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors

This position has not been approved for Relocation Assistance.

What Thermo Fisher Offers to Employees:

Medical, Dental, and Vision benefits effective on first day of employment

Paid Time Off – Eligible to accrue up to 3 weeks of Paid Time Off (PTO), pro-rated based on start date

Paid Holidays

401(K) Retirement Plan – Company Matching Contribution up to 6%

Shift Premium for 2nd and 3rd shift employees

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.