Quality Control (QC) Chemist – Dry Powder Inhaler (DPI)

Quality Control (QC) Chemist Dry Powder Inhaler (DPI)
Location: Hauppauge NY (On-site) Schedule: 8:30 AM 5:00 PM (flex based on production/testing needs)
Bring Precision to Every Breath
Step into a critical role where science meets patient impact. As a QC Chemist specializing in inhalation products youll play a vital role in ensuring the safety quality and performance of metered dose inhalers (DPIs) and related dosage forms that patients rely on every day.
This is not your average QC rolehere youll work on complex aerosol and particle-based delivery systems applying advanced analytical techniques to confirm product integrity and regulatory compliance in a highly controlled cGMP environment.
What Youll Do
Analytical Testing & Expertise

• Perform routine and advanced QC testing for pharmaceutical dosage forms with a strong focus on inhalation products (DPI systems)
• Evaluate critical quality attributes (CQA) such as particle size distribution spray pattern plume geometry and dose uniformity
• Operate and maintain advanced instrumentation:
• Gas Chromatography (GC)
• Particle Size Analyzers (e.g. laser diffraction cascade impaction)
• ICP (trace elemental analysis)
• Execute specialized inhalation testing protocols including propellant-based system assessments

• Apply working knowledge of raw materials propellants excipients and canister/valve systems specific to aerosol delivery
• Support testing across multiple dosage forms (solid oral liquids injectables topical and inhalation platforms)

• Ensure strict adherence to cGMP data integrity standards and ALCOA principles
• Investigate OOS deviations and atypical results contributing to root cause analysis and corrective actions

• Maintain accurate audit-ready documentation aligned with FDA and regulatory expectations
• Follow and continuously improve SOPs in a structured QC environment

• Bachelors degree in Chemistry Analytical Chemistry Pharmaceutical Sciences or Physics (highly preferred fields aligned with role expectations)
• Strong foundation in analytical techniques and data interpretation

• Proven experience in a pharmaceutical QC environment (required)
• Hands-on exposure to multiple dosage forms especially:
• Tablets/Capsules
• Liquid formulations
• Injectables
• Topicals
• DPI inhalation products (highly preferred)

• Experience specifically in Quality Control roles (primary function)
• Comfortable working in a fully onsite regulated lab environment with fixed schedules and SOP-driven workflows
• Strong communication skills and ability to interpret document and present scientific findings

• Operate in a state-of-the-art cGMP laboratory handling solvents powders and aerosol systems
• Required use of PPE: lab coats safety glasses respirators etc.
• May include shift flexibility (day/evening/night) and occasional weekends based on production demands

• Stand/walk for extended periods (75% of shift)
• Lift up to 10 kg as needed
• Perform detailed lab work requiring precision and focus