Pharma Analytical Chemist — GMP/FDA Method Validation

Nivagen Pharmaceuticals

Sacramento (CA)

On-site

USD 65,000 - 95,000

Full time

6 days ago

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Job summary

Nivagen Pharmaceuticals is seeking a chemist to perform analytical testing on pharmaceutical products to ensure regulatory compliance with FDA/ICH guidelines. The role involves working with GC, LC-MS, HPLC, and related detectors in a GMP/GDP environment.

The candidate should have 1–5 years of experience in a pharmaceutical QC laboratory, a chemistry-related degree, and strong documentation skills. The position emphasizes accuracy, traceability, and collaboration with R&D, production, and QA

Qualifications

Bachelor’s or Master’s degree in Chemistry or related field.
1-5 years of experience in a pharmaceutical quality control laboratory.
Experience with GMP, GLP, and GDP requirements.

Responsibilities

Operate and maintain analytical instruments (GC, LC-MS, HPLC, etc.).
Calibrate and maintain lab equipment to ensure accuracy.
Develop and validate analytical methods per ICH and FDA guidelines.
Perform qualitative and quantitative analyses on raw materials and finished products.
Conduct stability studies following ICH guidelines.
Investigate deviations and implement CAPA.
Ensure GLP, GMP, GDP compliance.
Assist in regulatory inspections and audits.
Collaborate with R&D, production, and QA.