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PDS Tech Inc Chemist in Fenton, Missouri

Coordinate with other Quality Control chemists, R&D researchers and formulation specialty

and other manufacturing departments to ensure high quality standards are always met.

Responsibilities:

  • Follow cGMP, cGLP, and OSHA guidelines with regard to work practices and safety

  • Perform a variety of analytical procedures in the analysis of pharmaceutical products and raw materials by various testing techniques including but not limited to Wet Chemistry, GC, HPLC, UV-Vis, FTIR, and Dissolution etc.

  • Qualify, calibrate, and maintain chemical laboratory equipment

  • Read, understand and interpret analytical procedures

  • Document work clearly and perform test accurately

  • Peer review data and reports

  • General laboratory maintenance

Skills and Abilities Required:

  • Minimum 2-3 year of experience in USP method / inhouse method of analysis

  • Minimum 2-3 years of experience preparing cGMP and other laboratory documents

  • Minimum 2-3 years of experience with cGMP and FDA regulations

  • Proficient in chromatography software

  • Excellent organizational and problem-solving skills

  • Sound knowledge of laboratory apparatus and equipment and a variety of laboratory techniques and work independently with minimum supervision.

  • Proficient in Microsoft Word, Excel, and PowerPoint

  • Experience in HPLC, dissolution handling,

  • Experience troubleshooting the HPLC and GC

  • Experience with ICH, DEA, Head Space, and IC regulation knowledge

  • Proficient in Chromeleon and Chemstation software or other similar 21 CFR compliant software.

  • USP, BP, EP, and JP methods of analysis

  • Ensure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines.

Minimum Education and Experience Required:

Bachelor’s degree in Chemistry with a minimum of three (3) years of laboratory experience, preferably in the pharmaceutical industry; or

Master’s degree in Chemistry with a minimum of three (2) years laboratory experience, preferably in the pharmaceutical industry

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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