QC Scientist – Raw Materials & Pharmacopoeia Testing QC Scientist – Raw Materials & Pharmacopoe

QC Scientist – Raw Materials & Pharmacopoeia Testing

Eurofins

In-person
· Gaithersburg, MD, US

2 days ago

Eurofins PSS is seeking a QC Scientist – Raw Materials & Pharmacopoeia Testing to support the launch and operation of a new GMP raw materials testing laboratory. This role will focus on performing analytical and compendial testing of pharmaceutical raw materials in accordance with USP/NF, European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP) requirements.

The ideal candidate will have hands‑on experience with raw materials testing, pharmacopoeial methods, wet chemistry techniques, and instrumental analysis, including HPLC, UPLC, GC, and FTIR
. This individual will play a key role in maintaining data integrity, supporting laboratory investigations, and contributing to the successful implementation of new methods and processes in a start‑up laboratory environment.

Training will be conducted in both Gaithersburg, MD, and Frederick, MD
.

• Perform raw materials testing in accordance with GMP requirements, approved procedures, and applicable pharmacopoeial monographs and general chapters
• Execute compendial and physicochemical testing, including appearance, identification, pH, and wet chemistry analyses
• Perform chromatographic and spectroscopic testing using HPLC, UPLC, GC, and FTIR instrumentation
• Interpret and evaluate analytical results against established specifications and acceptance criteria
• Document laboratory activities in accordance with ALCOA+ principles using laboratory notebooks, electronic systems, logbooks, and worksheets
• Troubleshooting laboratory instruments and performed routine equipment maintenance activities
• Support laboratory investigations, including deviations, invalid assays, OOS/OOT events, CAPAs, and change controls
• Author and revise SOPs, test methods, protocols, and associated GMP documentation
• Conduct data review, logbook review, and documentation review activities
• Support implementation, transfer, and continuous improvement of compendial and analytical methods
• Maintain laboratory organization and efficiency through Lean and continuous improvement initiatives
• Assist with inventory management, reagent preparation, sample receipt, storage, and disposal activities
• Collaborate effectively with cross‑functional teams while managing multiple priorities in a fast‑paced environment