QC Analytical Chemist

About the role

Eurofins PSS is currently hiring for a QC Analytical Chemist to support GMP testing of pharmaceutical in-process, raw materials, intermediates, APIs, and stability samples. In addition, the successful candidate will support investigations of invalid results and method transfer activities. This individual will have high attention to detail and possess excellent organizational skills.

Key Responsibilities

Conduct testing and review in accordance with approved methods, specifications, protocols, and compendial requirements Follow protocols for GMP regulations, including 21 CFR Parts 210 and 211, and applicable ICH guidelines Testing of pharmaceutical samples including in-process, raw materials, intermediates, API, stability, and more.

Participate in method transfer, qualification, and verification studies Support investigations for OOS, OOT, and invalid results Utilize various analytical techniques including: NMR, GC, LC, ICP-OES, IR, RI, UV-Vis, Conductivity, Specific Rotation, Titration, TGA, and more Reference standard qualification and management Elemental impurities and residual solvent testing and review

Qualifications & Requirements

Basic

Minimum Qualifications

BS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related degree with at least a year of GMP/GLP testing experience; OR MS in Chemistry, Pharmaceutical Sciences, Life Sciences, or related degree with at least 6 months of industry GMP/GLP testing experience At least a year of industry experience with Liquid Chromatography (LC), Conductivity, and Titration Proven experience utilizing at least two of the following techniques and/or instruments: Nuclear Magnetic Resonance (NMR), Gas Chromatography (GC), Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Infrared Spectroscopy (IR), Refractive Index (RI), Ultraviolet-Visible (UV-Vis), Thermogravimetric Analysis (TGA) Knowledge and in-depth understanding of GMPs, ICH, and 21 CRF guidelines Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications

At least a year of GMP experience

Additional Information

This position is a permanent, full-time role with overtime as needed. Schedule: 6:00 AM - 4:30 PM, 10-hour shifts, four days per week, 40 hours per week: either Sunday - Wednesday or Wednesday - Saturday.