Chemist II - Analytical Chemistry (HPLC, cGMP)

Chemist II - FDA cGMP Analytical Lab | 100% Onsite | Growing Pharmaceutical Testing Laboratory

This Jobot Job is hosted by: Ron Calhoun
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $70,000 - $80,000 per year

A bit about us:

Founded over 20 years ago and based in South Plainfield, NJ, we are an FDA-registered, cGMP-compliant analytical testing laboratory specializing in OTC drugs, pharmaceuticals, cosmetics, dietary supplements, and botanical products. We provide method development, validation, stability testing, and release testing services to support regulatory compliance and product quality. Our laboratory operates under strict FDA, DEA, ISO, and USP standards to ensure accurate, reliable analytical results for our clients.

Why join us?

• Competitive Compensation: Market-aligned base salary (DOE)
• Stability & Growth: Established FDA-regulated analytical lab
• Hands-On Technical Role: Extensive instrumentation exposure (LC, ICP-MS, UV, IR, dissolution, etc.)
• Regulatory Experience: Work directly in FDA cGMP-compliant operations
• Professional Development: Exposure to method development, validation & QA collaboration
• Team Environment: Work closely with Laboratory and QA associates
• 100% Onsite - Fully equipped laboratory setting

Job Details

Key Responsibilities and Duties

• Independently execute validated analytical methods using LC, IR, UV, dissolution, viscosity, melting point, and related instrumentation
• Prepare samples of OTC drug, pharmaceutical, cosmetic, dietary supplement, and botanical products
• Process and review instrument data (LC, ICP-MS, etc.) for QA-ready reporting
• Maintain detailed, compliant documentation in accordance with FDA cGMP requirements
• Support method development, verification, validation, and transfer activities
• Participate in investigations including deviations, OOS/OOT, and CAPA
• Maintain laboratory equipment including calibration and troubleshooting
• Adhere to OSHA, chemical safety, and waste disposal procedures
• Occasionally assist with microbiology-related activities (media prep, environmental monitoring, aseptic handling)

You should have most of the following:

• Bachelor's degree in Chemistry (required)
• Minimum 3-5 years of experience in an industry chemistry lab (FDA-regulated preferred)
• Strong hands-on experience with HPLC methods
• Experience working in FDA cGMP environments
• Familiarity with USP, ICH, and related regulatory guidelines
• Experience participating in OOS/OOT investigations and CAPA
• Ability to work independently in a fast-paced lab setting
• Basic microbiology exposure (media prep, aseptic techniques, environmental monitoring)
• Must be legally authorized to work in the US
• Must be able to commute to South Plainfield, NJ (no relocation)
• This is a 100% onsite role

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

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