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.
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.