Pharma QC Chemist: Analytical Methods & GMP Compliance

Nivagen Pharmaceuticals, Inc.

Sacramento (CA)

On-site

USD 70,000 - 110,000

Full time

2 days ago

Be an early applicant

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a chemist to perform analytical testing on raw materials, intermediates, and finished dosage forms in a GMP-regulated lab in California. You will ensure product safety, efficacy, and quality in line with FDA/ICH standards.

Responsibilities include operating GC/LC-MS/UHPLC systems, validating methods, and supporting regulatory submissions. The role requires strong problem-solving, documentation, and cross-functional collaboration with QA, R&D, and

Qualifications

Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
1-5 years of experience in a pharmaceutical quality control laboratory.
Experience with GMP, GLP, and GDP requirements.
Proficiency with analytical techniques (HPLC, GC, UV-Vis, FTIR) and method validation.

Responsibilities

Operate and maintain analytical instruments (GC, GC-MS, LC-MS, UPLC, HPLC) with detectors (UV-Vis, PDA, CAD).
Calibrate and maintain laboratory equipment to ensure accuracy and precision.
Develop and validate analytical methods compliant with ICH and FDA guidelines.
Perform qualitative and quantitative analyses on materials and finished products.
Conduct stability studies per ICH guidelines and document results for regulatory submissions.
Investigate deviations and conduct CAPA to address root causes.
Ensure testing adheres to GLP, GMP, GDP, and other regulatory standards.
Assist in audits and collaborations with R&D, production, and QA teams.