Must have a Bachelor’s Degree in Chemistry or related science.
5 + years’ experience in a regulated industry (i.e. pharmaceutical, dietary supplement, biotech, etc); or equivalent combination of education, training and/or experience.
2 to 3 years of experience with USP/AOAC is required.
Hands-on experience with chromatography equipment is required.
Experience with EP, BP, ACS, and ICH guidelines is preferred.
Experience with Waters HPLC equipment and Empower 3 Chromatography Software is preferred.
Experience with preventive maintenance and calibration of instruments is preferred.
Experience working in a regulated (i.e. FDA, NPA, etc) GMP environment is required.
Experience with analytical method verification, development, validation or transfer, is required.
Experience in operating, maintaining, and troubleshooting instruments is preferred.
Experience using analytical instrumentation including analytical balances, TOC, spectrophotometers, etc. is required.
Experience in maintaining data integrity is required.
Experience reviewing audit trails a strong plus.