QC Scientist – Raw Materials (Compendial Testing Focus)
Eurofins•Gaithersburg, MD
•$31 - $40•Onsite
About The Position
Eurofins PSS is seeking a QC Scientist with strong compendial assay experience to support the launch of a new raw materials testing laboratory. This is a hands-on role ideal for candidates experienced in USP/NF, Ph. Eur., and JP monograph testing, looking to apply their expertise in a growing GMP environment. You’ll play a key role in ensuring raw materials meet quality and regulatory standards through compendial and wet chemistry testing, while contributing to the buildout of a new lab.
Requirements
- BS in Chemistry, Biochemistry, or related field
- 3+ years pharmaceutical QC experience with a strong focus on compendial testing
- Hands-on experience performing USP/NF, Ph. Eur., or JP monograph assays
- Experience with raw materials testing and physicochemical methods
- Proficiency in HPLC/UPLC, GC, and FTIR
- Strong understanding of cGMP documentation and data integrity
Nice To Haves
- Experience supporting compendial method transfers, verifications, or troubleshooting
- Familiarity with OOS/OOT investigations tied to compendial assays
- Lean/6 Sigma exposure
- Ability to thrive in a startup or build-phase lab environment
Responsibilities
- Perform compendial raw materials testing in accordance with USP/NF, Ph. Eur., and JP monographs
- Execute physicochemical assays including appearance, pH, titrations, and wet chemistry methods
- Run and interpret HPLC/UPLC, GC, and FTIR analyses in support of monograph requirements
- Review and evaluate results against specifications; identify OOS/OOT trends
- Author and revise SOPs related to compendial methods and raw materials testing
- Support deviations, investigations, CAPAs, and change controls
- Troubleshoot analytical methods and instrumentation
- Maintain cGMP-compliant documentation aligned with ALCOA principles
- Contribute to lab startup activities, method implementation, and continuous improvement
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
