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Confidential

QC Chemist III

Confidential, Hauppauge, New York, United States, 11788

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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.