Quality Control Chemist

Position Title: Quality Control Chemist Department: Quality Control
Reports To: Supervisor of Quality Control Work Location: Decatur, Illinois

Position Summary:
The Quality Control Chemist will perform testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations that require chemical analysis.

Essential Duties and Responsibilities:
• Experience in method validation and method transfers activity of injectable, ophthalmic drug products, drug substances, raw materials, etc.
• Perform the method validation and method transfer activity per ICH/USP requirements.
• Responsible for writing method validation, verification protocol, and reports.
• Responsible for writing test method, specifications, 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
• Experience in integration of chromatograms through chromeleon chromatographic software.
• Review of analytical method/ specification and prepare GAP analysis.
• Coordinate with R&D lab for method validation/ method transfer related query/questions.
• Responsible for writing an investigation report for OOS/OOT if any.
• Preparation of stability schedule, Protocol and report per 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.

Position Requirements:
  • Bachelor’s degree in Chemistry
  • Two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.
Specialized Training or Technical Knowledge Licenses, Certifications Needed:
• Working knowledge of MS Word, Excel, Outlook, and Power Point
• Working knowledge of Adobe Acrobat
Functional Knowledge:
• Excellent conceptualizing, analytical and problem-solving skills

Job-Specific Competencies:
• Effective written and oral communication skills
• Strong organizational, planning, and communication skills.
• Demonstrates exceptional time management 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

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