QC Scientist – Raw Materials (Compendial Testing Focus)

Job Description

Make an Impact Where Compendial Expertise Matters

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.

What You’ll Do

• 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

Qualifications

Required

• 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

Preferred

• 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

Additional Information

Position is Full Time, Monday-Friday, 8am-5 pm. Candidates currently living within a commutable distance of Gaithersburg, MD, are encouraged to apply

Excellent full-time benefits include:

• 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
• Base Compensation: $31-$40 per hour based on education and experience

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.