Quality Control Analyst II

What You’ll Do

The QC Analyst II performs analytical chemistry testing and laboratory activities supporting raw materials, in-process samples, finished goods, and stability programs under cGMP conditions, ensuring product quality, regulatory compliance, and timely release of materials. In this role, you develop subject matter expertise in analytical testing methodologies, laboratory instrumentation, and quality control systems within regulated pharmaceutical and medical device environments.

• Perform analytical testing of incoming raw materials according USP, EP, ACS Reagent Index, and approved internal methods.
• Execute analytical chemistry assays for in-process, release, stability, Engineering, and R&D samples using chromatographic, spectroscopic, and wet chemistry techniques.
• Operate and maintain laboratory instrumentation including HPLC, GC, GC/MS, UV/Vis spectrophotometers, FTIR spectrophotometers, pH meters, osmometers, TOC analyzers, conductivity meters, viscometers, and titration systems.
• Perform analytical testing using techniques such as Karl Fischer moisture analysis, headspace analysis, auto and manual titrations, viscosity testing, and compendial identification testing.
• Complete laboratory documentation and data recording activities in accordance with Good Documentation Practices (GDP), cGMP requirements, and internal procedures.
• Review laboratory notebooks, verify analytical results, and support data integrity and compliance activities.
• Collaborate with R&D and cross-functional teams to support development, transfer, qualification, and validation of analytical test methods for new products and processes.
• Research, optimize, qualify, and validate analytical methods in accordance with industry best practices and regulatory expectations.
• Report deviations and nonconformances, participate in laboratory investigations, and support implementation and closure of corrective actions.
• Maintain training compliance for assigned procedures, laboratory techniques, and safety requirements.
• Perform routine maintenance and upkeep of general laboratory equipment and instrumentation.
• Support continuous improvement initiatives and participate in additional projects as assigned.

This role requires the ability to work on analytical and laboratory assignments of moderate complexity where data analysis and interpretation require evaluation of variable factors and sound scientific judgment. The position operates within established procedures and quality systems while exercising initiative in troubleshooting, prioritization, and execution of laboratory activities. Success in this role requires strong technical laboratory skills, attention to detail, effective organization, and the ability to manage multiple priorities in a regulated manufacturing environment.

• Bachelor’s degree in Chemistry, Physical Science, or related scientific discipline; equivalent experience may be considered.
• 2–5 years of analytical testing experience within FDA-regulated pharmaceutical or medical device industries.
• Demonstrated knowledge of GMP and ISO regulatory requirements.
• Hands‑on experience with HPLC and GC analyses, including method development and method validation activities.
• Experience using laboratory instrumentation including UV/Vis spectrophotometers, FTIR spectrophotometers, pH meters, and osmometers.
• Skilled in wet chemistry techniques including titrations and compendial identification testing.
• Strong documentation, organizational, and problem‑solving skills.
• Ability to manage multiple priorities and meet established timelines in a fast‑paced laboratory environment.
• Willingness and flexibility to support varying work schedules as needed to complete laboratory activities.

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