Sr Quality Specialist
Thermo Fisher Scientific
Summary
The Senior Quality Specialist – Project Lead at Thermo Fisher Scientific plays a crucial role in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations. This position is responsible for maintaining full company compliance to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction.
Job description
How Will You Make an Impact
The Senior Quality Specialist – Project Lead at Thermo Fisher Scientific plays a crucial role in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations. This position is responsible for maintaining full company compliance to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction.
A Day in the Life
- Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations.
- Oversees the quality of methods, processes, materials, and products by coordinating and reviewing group operations, providing staff training, and assessing/improving systems and processes.
- Responsible for reviewing and approving procedures, training documents, forms, deviation, and change control of moderate to high complexity.
- Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety, and business risks.
- Act as a technical resource for system support and new product introduction by interpreting regulatory requirements and establishing systems.
- Makes decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering the level of risks related to compliance and product quality.
Education
- Bachelor degree required, preferably in technology, engineering, scientific field or related area.
Experience
- Minimum 5 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required.
- Equivalent combinations of training, and meaningful work experience may be considered if at least a bachelor degree is acquired.
Knowledge, Skills, Abilities
- Project management expertise
- Strong knowledge of regulatory requirements and quality standards
- Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing.
- Professional certifications (e.g., CQA) and training in Six Sigma are beneficial.
- Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence is essential.
- Ability to work independently and to remain firm in complex situations is required in this fast-paced environment.
Requirements
- Bachelor degree required, preferably in technology, engineering, scientific field or related area.
- Minimum 5 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required.
- Project management expertise
- Strong knowledge of regulatory requirements and quality standards
- Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing.
- Professional certifications (e.g., CQA) and training in Six Sigma are beneficial.
- Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence is essential.
- Ability to work independently and to remain firm in complex situations is required in this fast-paced environment.
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.