Quality Assurance Engineer III

1 month ago


Plainville, Massachusetts, United States Thermo Fisher Scientific Full time
Work Schedule
First Shift (Days)

Environmental Conditions
Office

Job Overview

As a valued member of the Thermo Fisher Scientific team, you will engage in impactful work that contributes positively on a global scale. Collaborate with colleagues to realize our Mission daily, empowering our customers to create a healthier, cleaner, and safer world. We equip our global teams with the necessary resources to achieve personal career aspirations while advancing science by developing solutions for some of the most pressing challenges, such as environmental protection, food safety, and cancer research.

Location/Division Specific Information

This position supports our Viral Vectors (VVS) Plainville Business Unit.

Discover Meaningful Work:

At Thermo Fisher Scientific, we present an exceptional opportunity for a Quality Engineer III to make a substantial impact. In this role, you will be instrumental in ensuring that quality standards for products, processes, systems, or equipment are met. Your duties will encompass reviewing and approving validation documentation for clinical and commercial drug manufacturing related to cell and gene therapy products. You will be a vital contributor to our esteemed Quality System.

A Day in the Life:
  • Develop Quality Assurance programs and systems to guarantee product quality and adherence to regulatory standards.
  • Examine data from validation tests to assess whether systems and processes fulfill required criteria and specifications.
  • Lead teams in establishing and refining procedures to ensure proper processes and testing are executed.
  • Assess current and emerging regulations, conduct gap analyses, and implement necessary actions to address deficiencies.
  • Set short and long-term objectives, critical metrics, and goals to effectively execute Quality initiatives.
  • Analyze trends and collaborate with Validation to investigate, perform root cause analysis, recommend corrective measures, and review data to enhance processes and products.
  • Engage directly with customers to resolve Quality concerns and guide issue resolution.
  • Design Quality Assurance programs and systems for product and/or process development, manufacturing, and testing.
  • Evaluate data from validation tests to ensure compliance with regulatory standards and specifications.
  • Guide teams in creating and modifying procedures to meet required benchmarks.
  • Review regulations, conduct gap analyses, and implement necessary actions to address deficiencies.
  • Establish short and long-term objectives, critical metrics, and goals.
  • Investigate trends, address issues, recommend corrective actions, and analyze data to enhance processes and products.
Keys to Success:

Education
  • Bachelor's degree in mechanical, chemical, biomedical, engineering, or a related discipline is required.
Experience
  • A minimum of 3 years of experience in a Quality or Validation role within a regulated environment is necessary.
  • Direct validation experience is preferred.
Knowledge, Skills, Abilities
  • Ability to work collaboratively in multi-functional teams.
  • Familiarity with Quality standards such as 21 CFR Part 820 and ISO.
  • Understanding of cGMPs and FDA/Industry expectations.
  • Acquainted with a variety of concepts, practices, and procedures.
  • Strong interpersonal skills and the capacity to manage critical matters with diplomacy.
Benefits:

We provide competitive compensation, an annual incentive plan bonus scheme, healthcare, and a variety of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, along with outstanding career and development opportunities. We foster an exciting company culture that emphasizes integrity, intensity, involvement, and innovation.

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