Chemist

Position Summary:

Perform the sampling of raw materials, chemical and physical analysis of raw material, bulk formulations, finished products, stability samples, and any non-routine samples.

Essential Duties & Responsibilities:

·      Sampling and testing of raw materials per approved procedure.

·      Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.

·      Upkeep of laboratory notebook.

·      Maintaining the work area in an orderly manner.

·      Maintaining Lab inventory like list of standards, chemical, reagent etc.

·      Recording daily activity like PH verification, balance verification, temperature and humidity monitoring of lab stability chambers, freezer, refrigerator etc.

·      Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc.

·      Perform Finished product/in-process/cleaning validation and raw material analysis independently.

·      Complete testing within specified timeframes and document results accurately

·      Coordinate with vendor for instrument PM, calibration and qualification activity.

·      Provide necessary support.

·      Maintain and monitor lab GLP activity like instrument calibration/qualification schedule, Preparation of instrument operating procedure, coordinate with metrology team and vendor for scheduling period calibration/qualification activity etc.

·      Performs calibration of lab instruments whenever possible.

·      Cleaning of laboratory glassware.

·      Responsible for writing SOP for instrument operation/ calibration etc.

·      Provide necessary support for OOS/OOT investigation.

·      Preparation of stability schedule, Protocol, and report per ICH requirements.

·      Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation.

·      Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) during testing procedure.

Education and Experience:

·      Bachelor's Degree from a four-year accredited college or university with a Major in Chemistry or equivalent.

·      Prefer, two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.

·      Experience with, Infra-Red (IR), Ultraviolet/Visible Spectroscopy, Particle Size Analysis, KF Titration, and wet chemistry skills are required.

·      Familiarity with High Pressure Liquid Chromatography, Gas Chromatography (GC), and HPLC/GC analytical software is preferred, but not required.

·      Familiarity with GLP/GMP guidelines.

·      Good Communication and writing skills.

·      Familiarity with out-of-specification (OOS) investigation. Computer literate.

·      Experience with USP/EP monographs.