Job Description
Job Description
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.
salary: $29.99 - $30 per hour
shift: First
work hours: 9 AM - 5 PM
education: Bachelors
Responsibilities
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
Job Perks & Assignment Benefits
- 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.
Skills
- HPLC
- UPLC
- FDA regulations
- GMP
- OTC Products
- Sampling
- Years of experience: 2 years
- Experience level: Experienced
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.