Quality Assurance Specialist
2 weeks ago
We are seeking a highly skilled Quality Assurance (QA) Engineer to join our team at Thermo Fisher Scientific. As a QA Engineer, 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.
- 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.
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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