Quality Assurance Specialist

7 days ago


Plainville, Connecticut, United States Thermo Fisher Scientific Full time
About the Role

We are seeking a highly skilled Quality Engineer II to join our team at Thermo Fisher Scientific. As a Quality Engineer II, you will play a critical role in ensuring that quality requirements for products, processes, systems, or equipment are fulfilled.

Key Responsibilities
  • Review and approve validation documentation for clinical and commercial drug manufacturing of cell and gene therapy products.
  • Craft Quality Assurance programs and systems to ensure product quality and compliance with regulatory requirements.
  • Analyze data from validation tests to determine if systems and processes meet required criteria and specifications.
  • Lead teams in building and modifying procedures to ensure appropriate processes and testing are conducted.
  • Evaluate current and new regulations, perform gap analyses, and take appropriate actions to resolve deficiencies.
  • Develop short and long-term goals, critical metrics, and objectives to efficiently implement Quality initiatives.
  • Analyze trends and team with Validation to investigate, conduct root cause analysis, recommend corrective actions, and analyze data to improve processes and products.
Requirements
  • Bachelor's degree in mechanical, chemical, biomedical, engineering, or a related field required.
  • At least 3 years experience in a Quality or Validation function in a regulated environment.
  • Direct validation experience is desired.
  • Ability to collaborate effectively in multi-functional teams.
  • Familiarity with Quality standards such as 21 CFR Part 820 and ISO 13485.
  • Knowledge of cGMPs and FDA/Industry expectations.
What We Offer

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits. 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.



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