Senior QC Scientist - Pharma Analytics & Validation

RXinsider LTD.; Piscataway Township (NJ); On-site; USD 115,000 - 120,000; Full time

Job summary

Amneal is seeking a Senior Scientist, Quality Control to perform comprehensive testing of raw materials, in-process, and finished products, including stability testing. You will validate methods, calibrate HPLC/GC instruments, and ensure compliance with SOPs and cGMP standards.

Responsibilities include data review, investigations, and supporting non-routine projects while maintaining strict documentation and quality control practices. This role is based in Piscataway, NJ.

Qualifications

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) and measuring physical parameters.
• Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Must have ability to troubleshoot complex analytical and instrument-related problems and report actions to management.
• Must be able to identify trends in analytical data.
• Must have 60 months of experience in the position or in a related position.

Responsibilities

• Perform testing of raw materials, in-process and finished dosage forms, and products on stability.
• Calibrate HPLC, GC, and other equipment; perform validation testing as assigned.
• Document steps and report results in specification documents.
• Assist with method transfer activities and investigations.
• Provide feedback on analytical systems and procedures for continuous improvement.

Skills

Analytical chemistry

cGMP knowledge

Data trend analysis

Troubleshooting

Documentation

Education

Bachelor's degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing

Tools

HPLC

GC

UV-Vis spectrophotometer

Infra-red spectrophotometer

Karl Fischer

Dissolution apparatus

pH meter

Job description

Amneal is seeking a Senior Scientist, Quality Control to perform comprehensive testing of raw materials, in-process, and finished products, including stability testing. You will validate methods, calibrate HPLC/GC instruments, and ensure compliance with SOPs and cGMP standards.

Responsibilities include data review, investigations, and supporting non-routine projects while maintaining strict documentation and quality control practices. This role is based in Piscataway, NJ.