QC Chemist III
14 hours ago
Hauppauge
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 • Bachelor’s 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.