Hightstown, New Jersey, United States
BS and MS degree in Chemistry with a decade of professional experience currently working at a compounding pharmaceutical facility. Skilled in High-Performance Liquid Chromatography (HPLC), High Performance Ion Chromatography (HPIC), dissolutions, as well as wet chemistry techniques. Have authored OOS, OOT reports and stability protocols. Participated in peer review of cGMP documentation and have provided input on how to achieve a more efficient QC laboratory to superiors. Recently acquired experience in Quality Systems Management department in a training capacity. Focused on curriculum development and provided classroom training. Additionally led initiatives to streamline the training program and authored several CAPAs.
Performed dissolution, blend uniformity, content uniformity, assay and related compound analysis in complying with protocols and methodologies formulated for finished product and stability samples for tablets and capsules. Performed the same analyses for in process samples in Research and Development phase. Operation of various instruments including high performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), UV-Vis spectrophotometer, Ion Chromatography, viscometer, Karl Fisher autotitrator, and other instruments used in physical testing. Manage and complete weekly schedule, interpreting data and adhering to cGMP guidelines on documentation when recording data, and reporting scientific results.
• Continued with the responsibilities pertaining to the Analyst position. • Conducted analysis without the direct supervision of laboratory supervisors. • Shared responsibly with department supervisor for troubleshooting instrumentation and scheduling several chemists. • Responsible for peer review and reporting of test results as a Project Leader for non-cGMP and cGMP projects.
• Set up, operated, and calibrated laboratory equipment and instruments with the assistance of laboratory supervisors. • Prepared and analyzed samples, standards, and solutions to determine physical and chemical characteristics. • Prepares and documents test results in lab records (notebooks, audit trails, standardized forms and other documentation). • Experience with various wet chemistry and elemental techniques such as Carbon, Hydrogen, Nitrogen and Oxygen analysis, halogen colorimetric titration methods, High Performance Liquid Chromatography (HPLC) and High Performance Ion Chromatography (HPIC). • Performed EP and USP wet chemistry and chromatography analysis.