Quality Control Chemist

Garonit PharmaceuticalFairfield, NJ
2d

About The Position

The QC Chemist is an analytical role responsible for HPLC testing, data analysis, and documentation in a cGMP pharmaceutical quality control laboratory. This position supports finished product testing, investigations, and continuous improvement while ensuring compliance with regulatory and compendial standards.

Requirements

  • Bachelor’s degree in Chemistry or related discipline with 5 years HPLC experience
  • or Master’s degree with 3+ years HPLC experience
  • Hands-on experience with Empower 3
  • Experience working in an FDA-regulated, cGMP environment
  • Knowledge of USP monographs, method development, and validation
  • Strong attention to detail and documentation skills
  • Excellent written and verbal communication skills

Responsibilities

  • Perform HPLC sample preparation, testing, and data analysis
  • Review and report analytical data in compliance with USP/ICH/cGMP requirements
  • Maintain and troubleshoot HPLC instrumentation
  • Execute compendial and non-compendial testing
  • Support investigations, CAPA, change controls, validations, and stability programs
  • Ensure laboratory safety and compliance
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