Position Title: Quality Control Chemist Department: Quality Control (STERILE INJECTABLE )
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.
- Experience with USP/EP monographs.