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ANALYTICAL CHEMIST I
- Perform analytical laboratory tests on a daily basis for Dosage Pharmaceuticals (such as purity, related substances, uniformity, dissolution, etc.) in accordance with approved methodology and cGMP, FDA, and DEA regulations when required.
- Set-up, adjustment, calibration, operation, and troubleshooting of laboratory equipment and instruments, as well as any associated software.
- Follow methods as written and must have an understanding of chromatographic theory to adjust methods as needed to improve resolution, etc.
- Preparation of solutions, solvents, and mobile phases.
- Accurate preparation and analysis of samples and reference standards.
- Accurate and timely documentation of all procedures, calculations, and results.
- Must be able to independently perform and adequately document investigations for out-of-specification/out-of-trend results.
- Review and approve analyses performed by other laboratory personnel for compliance to analytical methods, as well as cGMP, FDA, and DEA regulations.
- Complete assignments in a timely manner in accordance with current SOPs
- Work effectively in a team environment. Good oral and written communication skills.
- Comply with company, site , and safety policies / procedures.
- BS in Chemistry, Biology or related science field with equivalent work experience.
- A minimum of one year of relevant experience with HPLC and Dissolution is preferred
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