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.
Job Tags
Full time, H1b, Remote work, Work visa, Shift work, Weekend work, Afternoon shift,