Randstad USA
Direct message the job poster from Randstad USA
The R&D Stability Analytical Chemist is a critical, hands‑on role responsible for supporting the regulated drug product stability testing program and batch release testing. The successful candidate will work independently to manage critical analytical processes, operate and maintain advanced instrumentation with high precision, and ensure all testing is performed in strict accordance with ICH, FDA, and cGMP guidelines.
Core Responsibilities
Execute the regulated drug product stability testing program (real‑time and accelerated) as per
ICH Q1A (R2)
guidelines.
Provide essential analytical support for regulated drug product batch release testing.
Conduct daily testing, including sample preparation and analysis for: Active ingredients, preservatives, pH, water content, viscosity, color, odor, and appearance.
Support laboratory investigations related to Out‑of‑Tolerance (OOT), Out‑of‑Specification (OOS), and or chamber excursions.
Responsible for accurate data processing, stability data entry and review, and formal reporting.
Required Skills & Qualifications
Must have strong technical skills in analytical chemistry and instrument operation, specifically chromatography (HPLC, UPLC, GC) and atomic spectroscopy
Strong knowledge of
21 CFR 210/211, ICH, and FDA regulations
as they pertain to data integrity, stability, and cGMP is mandatory
Bachelors Degree in Science
Benefit from a flexible work week (on‑site 3 days, remote 2 days) in Melville, NY.
A competitive hourly rate of $30.00/hr.
Schedule: Mon‑Fri: 9:00 AM – 5:00 PM
Medical, Dental, Vision, and 401K
A company often recognized as being among the best in the prestige beauty industry
Please email michael.wilson@randstadusa.com for a faster response.
Job Details
Seniority level: Associate
Employment type: Contract
Job function: Product Management and Science
Industries: Pharmaceutical Manufacturing and Consumer Services
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The R&D Stability Analytical Chemist is a critical, hands‑on role responsible for supporting the regulated drug product stability testing program and batch release testing. The successful candidate will work independently to manage critical analytical processes, operate and maintain advanced instrumentation with high precision, and ensure all testing is performed in strict accordance with ICH, FDA, and cGMP guidelines.
Core Responsibilities
Execute the regulated drug product stability testing program (real‑time and accelerated) as per
ICH Q1A (R2)
guidelines.
Provide essential analytical support for regulated drug product batch release testing.
Conduct daily testing, including sample preparation and analysis for: Active ingredients, preservatives, pH, water content, viscosity, color, odor, and appearance.
Support laboratory investigations related to Out‑of‑Tolerance (OOT), Out‑of‑Specification (OOS), and or chamber excursions.
Responsible for accurate data processing, stability data entry and review, and formal reporting.
Required Skills & Qualifications
Must have strong technical skills in analytical chemistry and instrument operation, specifically chromatography (HPLC, UPLC, GC) and atomic spectroscopy
Strong knowledge of
21 CFR 210/211, ICH, and FDA regulations
as they pertain to data integrity, stability, and cGMP is mandatory
Bachelors Degree in Science
Benefit from a flexible work week (on‑site 3 days, remote 2 days) in Melville, NY.
A competitive hourly rate of $30.00/hr.
Schedule: Mon‑Fri: 9:00 AM – 5:00 PM
Medical, Dental, Vision, and 401K
A company often recognized as being among the best in the prestige beauty industry
Please email michael.wilson@randstadusa.com for a faster response.
Job Details
Seniority level: Associate
Employment type: Contract
Job function: Product Management and Science
Industries: Pharmaceutical Manufacturing and Consumer Services
#J-18808-Ljbffr