Quality Specialist II
Posted 1 month ago Expired
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Upload Your ResumeAbout This Role
The Quality Specialist II at Thermo Fisher Scientific ensures compliance with GMP standards and FDA regulations, supporting manufacturing operations across multiple product lines. This role involves implementing continuous improvement initiatives, conducting investigations, and maintaining quality management systems to advance global healthcare and scientific discovery.
Responsibilities
- Ensure compliance with GMP standards, FDA regulations, and international quality requirements
- Support manufacturing operations across multiple product lines
- Implement continuous improvement initiatives
- Conduct investigations
- Maintain quality management systems
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
- 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
- Ability to work in cleanroom environments and follow gowning procedures where required
- Ability to work various shifts to support manufacturing operations
- Able to stand/walk for extended periods and occasionally lift up to 25 lbs
Qualifications
- Advanced degree or Bachelor's degree in Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- 2+ years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment with a Bachelor's degree; no prior experience required with an advanced degree.
Nice to Have
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Additional language skills
Skills
* Required skills
About Thermo Fisher Scientific
Thermo Fisher Scientific is a company that enables customers to make the world healthier, cleaner and safer, providing solutions for some of the world's toughest challenges, across various industries including pharmaceutical, biotechnology, clinical labs, academia, government, environmental, and foo...