Quality Control Analyst

Job Title: QC Analytical Scientist

Location: Illinois, United States

Position Overview

The QC Analytical Method Development Scientist plays a key role in pharmaceutical product development by designing, developing, optimizing, and validating analytical methods for characterization, in-process controls, release testing, and stability studies. This role ensures all analytical activities comply with GMP/GLP regulations, ICH guidelines, and applicable regulatory requirements.

Essential Duties & Responsibilities

• Develop, optimize, and qualify analytical methods for small-molecule drug substances, drug products, excipients, and in-process materials.
• Utilize a wide range of analytical techniques including HPLC/UPLC, GC, LC–MS, dissolution testing, UV-Vis, FTIR, and compendial approaches.
• Evaluate method performance characteristics such as selectivity, sensitivity, accuracy, precision, linearity, and robustness, providing scientific justification for selected method conditions.
• Troubleshoot analytical methods and instrumentation to ensure consistent and reliable performance in a GMP laboratory environment.
• Draft, execute, and interpret validation protocols in alignment with 21 CFR Part 212, USP <823>/<825>, ICH Q2(R2), and relevant FDA guidance.
• Generate comprehensive method validation reports, technical justifications, and risk assessments.
• Perform statistical evaluations of method performance using industry-appropriate tools and practices.
• Maintain accurate, compliant, and complete GMP documentation according to ALCOA principles.
• Contribute to the preparation and revision of analytical method SOPs.
• Participate in cross-functional project teams to ensure analytical readiness for clinical and commercial supply.
• Support investigations, root cause analyses, and CAPA activities related to analytical methods or laboratory results.

Qualifications & Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 3–7 years of experience in pharmaceutical analytical development, method validation, or QC within a GMP-regulated environment.
• Experience with PET/SPECT radiotracers, sterile injectables, or radioactive drug products preferred but not required.
• Strong, hands-on expertise with HPLC/UPLC, GC, LC–MS, UV-Vis, FTIR, dissolution testing, and compendial methods.
• Solid knowledge of regulatory requirements including 21 CFR Part 212, 21 CFR Part 211, USP <825>, USP <823>, and relevant ICH guidelines.
• Familiarity with Empower and other GMP documentation/electronic systems.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent technical writing and communication abilities.
• Ability to manage multiple development projects and work independently in a fast-paced environment.