Quality Control Chemist

4 weeks ago

Decatur, United States Infojini Inc Full time

Job Title – Quality Control Chemist

Location – Decatur, IL 62522

Duration – Full time position

Shift Hours – MON-FRI

Job description:

• 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.


Company Overview:

• Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.

• Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.

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