Job Description

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.

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