QC Scientist – Raw Materials (Compendial Testing Focus)

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.

Youll 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 Youll 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.

Remote Work :

No

Employment Type :

Full-time