QC Chemist III Job at Confidential, Hauppauge, NY

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  • Confidential
  • Hauppauge, NY

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,

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