Ian Schildgen

Qc Chemist 1 @PCI Pharma Services

Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long-term stability, and validation samples. Assist in deviation investigation, out-of-specification or aberrant results, and process changes. Assist in authoring and/or review of GMP documentation including test methods, protocols, reports, and raw data. Perform analytical equipment validation, and ensure routine calibration and preventive maintenance are performed at the required intervals with support. Logging and tracking of samples and chemicals. Order chemicals and laboratory supplies as needed. Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely, and in compliance with cGMP/GDP requirements. Knowledge of analytical techniques using instruments such as UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer.