Job Title : QC Chemist III DPI (Dry Powder Inhalation)
Industry : Pharmaceutical Manufacturing
Location : Hauppauge, NY
Job Type : Full-Time | On-site
Work Hours : 8 : 30 AM 5 : 00 PM (may vary based on business needs)
Reports To : Quality Control Manager
Required Citizenship / Work Permit / Visa Status :
- US Citizen / Green Card Holder / TN Visa / H1B Transfers / OPT-EAD
About the Role
We are seeking a highly skilled QC Chemist III to join our Quality Control team in Hauppauge, NY. This position plays a critical role in ensuring compliance with cGMP and regulatory requirements while performing testing, method validation, and specialized analyses within a pharmaceutical QC laboratory. The focus will be on Dry Powder Inhalation (DPI) and other dosage forms , requiring expertise in both advanced analytical testing and leadership in investigations.
Key Responsibilities
Perform routine, advanced, and critical testing using validated methods and specialized instruments.Prepare and execute method validation, method transfer, and verification protocols .Conduct raw material testing, release, and cleaning validation (residue analysis) .Operate and maintain laboratory instruments including HPLC, GC, ICP, Karl Fisher, Particle Size Analyzer , etc.Lead investigation activities and provide technical support for root cause analysis.Ensure compliance with cGMP, data integrity, and good documentation practices (GDP) .Prepare detailed reports and maintain accurate laboratory records.Collaborate cross-functionally to support audits, regulatory inspections, and continuous improvement initiatives.Other duties as assigned by management.Education & Experience
Bachelors degree in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or related sciences required.Minimum 2 years of recent QC Chemist experience in a pharmaceutical manufacturing environment (generic pharma preferred).Strong experience with small molecules and regulated QC environments.Hands-on expertise with HPLC, GC, ICP, Karl Fisher, Particle Size Analyzer .Must have solid knowledge of cGMP, SOPs, and FDA regulations .Experience with Inhalation / DPI / MDI products is highly desirable.Excellent English communication skills (written, verbal, and technical discussions).Working Conditions
On-site role in a cGMP laboratory with mandatory PPE.May involve exposure to solvents, powders, and pharmaceutical raw materials.Standing / walking for 75% of shift; occasional lifting (up to 10 kg).Some evenings, weekends, or holidays may be required.No remote work available.