St. Louis, MO
Title: Analytical Chemist, QC
Function: Coordinate with other Quality Control chemists, R&D researchers and formulation specialists and other manufacturing departments to ensure high quality standards are always met.
Primary Responsibilities and Essential Functions of the Position:
- 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
- Other duties as assigned
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