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Chemist II Specialist
2 months ago
We are seeking a highly skilled Chemist II to join our team at RTI Surgical Inc. The successful candidate will be responsible for performing release testing on raw materials and finished products using USP compendial methods, client methods, and methods developed in-house.
Key Responsibilities:
- Develop and validate analytical methods for drug products, placebo, and raw materials in the Cook Biotech Analytical Laboratory.
- Perform quality control routine testing for raw material/Intermediate/Release/Stability testing.
- Troubleshoot methods and instrumentation, and communicate effectively with clients, both internal and external.
- Work with instrument qualification, including IQ, OQ, PQ, and calibration.
Requirements:
- Bachelor's degree in Chemistry or a related field.
- At least 2 years of laboratory experience.
- Familiarity with CGMPs and CFR 21-part 11 compliance.
- Experience with analytical method development in a CGMP laboratory setting is preferred.
- Proficiency in HPLC and experience with UV-Vis, Dissolution, FTIR, Karl Fischer, TOC, and general lab equipment.
Working Environment:
- Limited exposure to hazardous chemicals used in the manufacture of the product.
- Physical demands are typical of an office and classroom environment.