QC Chemist

Position 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 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.
  
  

Job Prerequisites

• Ability to meet attendance standards.
• At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
• Working knowledge of MS Word, Excel, Outlook, and Power Point.
• Working knowledge of Adobe Acrobat.
• Excellent conceptualizing, analytical, and problem-solving skills.
  
  

Physical Demands, Mental Requirements, And Work Environment

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.
• The employee is required to use hands to finger, handle, or feel.
• Specific vision abilities required by this job include close vision for written work and PC use.
• Requires eye-hand coordination and manual dexterity.
• Requires normal range of hearing and vision to record, prepare and communicate appropriate reports.
• Will come in contact with hazardous materials.
• Employee is expected to work with hazardous materials in a safe manner and use all safety precautions.
  
  

Mental Requirements

• Effective written and oral communication skills.
• Strong organizational, planning, and communication skills.
• Using logic and reasoning to identify solutions to problems.
• Ability to multi-task, set priorities, and meet strict deadlines.
• Ability to lead, motivate, coach, and teach others.
• Ability to accurately communicate ideas, facts, and technical information.
• Ability to meet deadlines and effectively deal with office stress.
• Ability to follow safety and security practices.
• Ability to receive instructions and follow work rules and company policies.
  
  

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