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.

Job Type: Full-time

Pay: $55,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• wet chemistry test procedures in a quality control env: 2 years (Required)
• Infra-Red (IR), Ultraviolet/Visible Spectroscopy,: 2 years (Required)
• KF Titration, and wet chemistry skills: 2 years (Required)
• Gas Chromatography (GC), and HPLC/GC: 2 years (Required)

Ability to Relocate:

• Decatur, IL 62522: Relocate before starting work (Required)

Work Location: In person