Perform testing on in-process material, Raw Materials, finished drug product, and stabilities in support of production and regulatory filings.
Experience
1 - 3 years experience in a cGMP laboratory setting
Familiar with cGMP and FDA requirements
Bachelor s Degree in Chemistry
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)
