Quality Specialist II - Complaints
Thermo Fisher Scientific
Summary
Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.
Job description
Description
Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.
Requirements
- Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
- Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
- Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent)
- Experience in deviation investigations, CAPA, change control, and root cause analysis
- Proficient in Microsoft Office suite and quality management software systems
- Technical writing and documentation skills
- Analytical and problem-solving abilities
- Clear verbal and written communication skills
- Ability to work independently and collaboratively in cross-functional teams
- Proactive and capable of managing multiple tasks and meeting deadlines in a fast-paced environment with minimal supervision
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Ability to work in cleanroom environments and follow gowning procedures where required
- Additional language skills may be beneficial
- Up to 10% travel may be required
- Must be able to work various shifts to support manufacturing operations
- Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
Requirements
- Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
- Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
- Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent)
- Experience in deviation investigations, CAPA, change control, and root cause analysis
- Proficient in Microsoft Office suite and quality management software systems
- Technical writing and documentation skills
- Analytical and problem-solving abilities
- Clear verbal and written communication skills
- Ability to work independently and collaboratively in cross-functional teams
- Proactive and capable of managing multiple tasks and meeting deadlines in a fast-paced environment with minimal supervision
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Ability to work in cleanroom environments and follow gowning procedures where required
- Additional language skills may be beneficial
- Up to 10% travel may be required
- Must be able to work various shifts to support manufacturing operations
- Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
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.