Position Title: Quality Control Chemist Department: Quality Control
Reports To: Supervisor of Quality Control Work Location: Decatur, Illinois
Position Summary:
Perform the sampling of raw materials, chemical and physical analysis of raw materials, 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.