QC Scientist – Raw Materials & Pharmacopoeia Testing

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

Qualifications

Minimum Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
• Minimum 3 years of pharmaceutical Quality Control laboratory experience
• Hands-on experience performing pharmaceutical raw materials testing
• Experience executing pharmacopoeial and compendial methods according to USP/NF, Ph. Eur., and/or JP requirements
• Experience with physiochemical testing, wet chemistry techniques, and raw materials release testing
• Proficiency with HPLC, UPLC, GC, and FTIR instrumentation
• Minimum 2 years of GMP laboratory experience
• Strong technical writing, documentation, and data review skills
• Proficiency with Microsoft Outlook, Excel, and Word
• Authorization to work in the United States without current or future sponsorship

Preferred Qualifications

• Experience supporting start-up laboratories or implementing new testing programs
• Strong understanding of data integrity principles and ALCOA+ requirements
• Familiarity with Lean, 5S, or continuous improvement methodologies
• Excellent troubleshooting and problem-solving skills
• Strong organizational and time-management abilities
• Ability to work independently while contributing effectively within a team environment
• Experience authoring investigations, CAPAs, change controls, and GMP documentation

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.