R&D/Mfg Scientist II-Reviewer
Thermo Fisher Scientific
Thermo Fisher Scientific seeks an R&D Scientist II-Reviewer to independently perform complex analytical data reviews for validations, development testing, and compliance activities in a laboratory setting in Greenville, North Carolina. The role requires expertise in cGMP standards, analytical techniques, and regulatory requirements.
Responsibilities
- Review cGMP analytical data across multiple techniques for procedural adherence and specification compliance
- Verify correct data entry into LIMS/SLIM systems and trend data for requirement validation
- Author and review out-of-specification investigations, deviations, and change control documents
- Support in-process, release, and stability testing activities while ensuring regulatory compliance
- Serve as subject matter expert for trainings and communicate project status to management
Requirements
- Associate degree in scientific discipline (Bachelor's preferred)
- 3-5 years pharmaceutical experience with 2+ years cGMP data review
- Advanced proficiency in Empower software
- Strong knowledge of HPLC, UV, FT-IR, and Karl Fischer Titration techniques
- Demonstrated expertise in method validation and analytical procedures
- Strong understanding of GMP, GLP, ICH guidelines, and USP/EP standards
- Excellent organizational, communication, and time management skills
Vacancy posted 14 days ago
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