Quality Control Analyst II

What You’ll Do

• Perform analytical chemistry testing and laboratory activities supporting raw materials, in-process samples, finished goods, and stability programs under cGMP conditions.
• Ensure product quality, regulatory compliance, and timely release of materials.
• Develop subject matter expertise in analytical testing methodologies, laboratory instrumentation, and quality control systems.

• Perform analytical testing of incoming raw materials (USP/EP/ACS Reagent Index and approved internal methods).
• Execute analytical chemistry assays for in-process, release, stability, Engineering, and R&D samples (chromatographic, spectroscopic, and wet chemistry techniques).
• Operate/maintain laboratory instrumentation (HPLC, GC, GC/MS, UV/Vis, FTIR, pH meters, osmometers, TOC analyzers, conductivity meters, viscometers, titration systems).
• Perform Karl Fischer, headspace, auto/manual titrations, viscosity testing, and compendial identification testing.
• Complete GDP/cGMP-compliant documentation; review results and support data integrity.
• Collaborate on method development/transfer/qualification/validation.
• Report deviations/nonconformances; support investigations and corrective actions.
• Maintain training compliance; perform routine equipment maintenance; support continuous improvement.

• Bachelor’s degree in Chemistry/Physical Science (or related); equivalent experience considered.
• 2–5 years analytical testing in FDA-regulated pharma or medical device industries.
• Knowledge of GMP and ISO regulatory requirements.
• Hands‑on HPLC and GC (method development/validation).
• Instrumentation experience (UV/Vis, FTIR, pH meters, osmometers).
• Wet chemistry skills (titrations; compendial identification).
• Strong documentation, organization, problem‑solving; manage multiple priorities.
• Flexibility to support varying work schedules.

• GC/MS, TOC analyzers, conductivity meters, viscometers.
• Analytical method transfers/qualification; stability testing/trending.
• Spreadsheets and basic graphs/trend reports.

• Discretionary bonus; comprehensive healthcare; HSA; 401(k) with up to 5% match; employee stock purchase plan (15% discount); accrued paid time off; long-term incentives including stock awards.