Perform testing on in-process samples, RMs, finished drug product, and stability study samples in support of production, packing release and regulatory filings.
Reporting Structure: Reports to QC lab Supervisor
Experience
3 - 6 years experience in a cGMP laboratory setting
Familiar with cGMP and FDA requirements
Bachelor s Degree in Chemistry or closely related degree.
Perform analytical testing and release of in-process material, bulk drug substance, finished drug product, and stability sample
Sampling, inspection and testing of raw materials and packaging components upon receipt
Responsible for Sampling of Bulk API and Bulk drums (API and Raw material)
Perform Calibration and minor troubleshooting on select laboratory equipment including GC, UV/Vis, IR, Potentiometer, Refractometer, Karl Fischer, Density meter and ICP/MS (with appropriate training)