QC Scientist – Raw Materials & Pharmacopoeia Testing QC Scientist – Raw Materials & Pharmacopoe[...]

Seeds Renewables; Gaithersburg (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

Eurofins is seeking a QC Scientist – Raw Materials & Pharmacopoeia Testing in Gaithersburg, MD. This role focuses on analytical testing of pharmaceutical raw materials adhering to USP/NF, European Pharmacopoeia, and Japanese Pharmacopoeia regulations.

The ideal candidate has experience with chromatographic techniques like HPLC and GC, and a strong understanding of GMP policies. Responsibilities include performing testing, documenting lab activities, and supporting laboratory investigations in a fast-paced environment.

Qualifications

• Experience with compendial and physicochemical testing.
• Ability to perform chromatographic and spectroscopic testing.
• Knowledge of GMP requirements and documentation.

Responsibilities

• Perform raw materials testing per GMP requirements.
• Execute compendial and physicochemical testing.
• Document laboratory activities following ALCOA+ principles.
• Support laboratory investigations, including deviations.
• Conduct data review and documentation review activities.

Skills

Hands-on experience with raw materials testing

Pharmacopoeial methods

Wet chemistry techniques

HPLC

UPLC

GC

FTIR

Job description

QC Scientist – Raw Materials & Pharmacopoeia Testing

Eurofins

In-person · Gaithersburg, MD, US

2 days ago

Job Description

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.

Responsibilities

• 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