QC Scientist – Raw Materials & Pharmacopoeia Testing

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

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

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.

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we focus on helping our team members grow professionally while gaining valuable industry experience. We provide opportunities to build a rewarding career in the biopharmaceutical industry through supportive teams, meaningful work, work-life balance, and a competitive benefits package.

Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services to clients across multiple industries. From the food you eat and the water you drink to the medicines you rely on, Eurofins works with organizations around the world to ensure products are safe, authentic, and compliant with regulatory requirements.

If you're looking for a rewarding career and a place to grow, apply today.