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Thermo Fisher Scientific - Plainville, MA
posted about 1 month ago
About the position
As a Quality Assurance (QA) Engineer II at Thermo Fisher Scientific, you will play a critical role in ensuring that quality requirements for products, processes, systems, or equipment are fulfilled. This position supports the Viral Vectors (VVS) Plainville Business Unit and involves reviewing and approving validation documentation for clinical and commercial drug manufacturing of cell and gene therapy products. You will contribute to the world-class Quality System and help develop solutions for some of the world's toughest challenges.
Responsibilities
- 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.
- Work directly with customers to address Quality issues and lead issue resolution.
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.
- Familiarity with a variety of concepts, practices and procedures.
- Strong interpersonal skills and the ability to handle critical matters with tact.
Benefits
- Competitive remuneration
- Annual incentive plan bonus scheme
- Healthcare
- Range of employee benefits
- Career and development prospects
- Innovative company culture that stands for integrity, intensity, involvement, and innovation.
