Quality control - GC Analyst
Job Description
Perform daily analysis of raw materials, in-process samples, and finished formulations using Gas Chromatography (GC).
Operate, calibrate, and troubleshoot GC instruments including FID, TCD, and HS-GC systems per standard SOPs.
Prepare chemical standards, reagents, and samples accurately following cGMP, GLP, and pharmacopoeial guidelines (USP, IP, EP).
Conduct method transfer, verification, and routine testing for residual solvents, assay, and organic impurities in formulations.
Record, document, and review all analytical raw data and test results in logs or LIMS in compliance with 21 CFR Part 11 and data integrity standards.
Report out-of-specification (OOS), out-of-trend (OOT), and atypical results promptly, assisting in lab investigations and root cause analysis.
Maintain, clean, and perform preventive maintenance on GC columns, injectors, detectors, and gas supply systems.
Manage inventory of GC column consumables, analytical standards, gases, and reference standards to ensure uninterrupted testing.
Support internal, regulatory, and customer audit readiness by maintaining strict compliance with safety, quality, and environmental protocols.
Write, revise, and execute SOPs, test procedures, protocols, and stability study reports for QC GC operations.