Job Description:
- 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 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, and 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.
Job Type: Full-time
Pay: $55,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Morning shift
- Overnight shift
Ability to Relocate:
- Decatur, IL 62521: Relocate before starting work (Required)
Work Location: In person