Live opening · Posted 5 days ago
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About the role
Description supplied by the original job listing.
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
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
Employment type
Full-time
Work arrangement
No
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