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Quality Control Chemist
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Quality Control Chemist
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Infojini Inc Decatur, United StatesJob Title – Quality Control Chemist · Location – Decatur, IL 62522 · Salary - Negotiable + Relocation Expenses + Full Benefits · Duration – Full time position · Shift Hours – MON-FRI · Job description: · • Perform the sampling of raw materials, chemical and physical analysis of r ...
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Quality Control Chemist
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Reuben Cooley Inc Decatur, United States Full time· • Candidate must have strong pharmaceutical quality control experience (Preferably injectable). · • Candidate should handle major QC instrument like HPLC,GC,UV,FTIR,KF etc. · • Candidate should have work experience for handling software like chromeleon ,Lab X etc. · • Candi ...
Quality Control Chemist - Decatur, United States - Infojini Inc
Description
Job Title – QC Chemist
Location – Decatur, IL
Duration – Permanent Position + Full benefits + Relocation assistance + Interview travel exp. assistance
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, 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.
· Familiar with liquid, sterile injectables a plus.