PI
Job Description
Job description
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)
