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: 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. Compensation: $31-$31 Eurofins USA PSS Insourcing Solutions