Description

You will perform chemical testing on commercial, validation, and stability samples using established methodologies.

Responsibilities

• Execute qualitative and quantitative analyses using HPLC, GC, UV/Vis, KF, and FTIR instrumentation.
• Analyze analytical data against approved specifications and report OOS or aberrant results to management.
• Participate in root cause investigations and provide input for corrective and preventive actions.
• Maintain laboratory documentation, including notebooks and electronic records, in compliance with GMP and GLP.
• Perform routine equipment maintenance and peer reviews of laboratory testing.
• Troubleshoot method and instrument issues by choosing between defined alternatives.

Required Skills

• 5+ years of experience in a laboratory or quality control environment.
• Proficiency with analytical instrumentation: HPLC, GC, UV/Vis, KF, and FTIR.
• Experience using LIMS and Empower for data acquisition and processing.
• Working knowledge of USP, cGMP, and FDA regulations.
• Ability to work independently with limited supervision on routine assignments.
• Strong documentation skills following GMP and GLP standards.
• Bachelor's degree or equivalent graduate level education.

Key Skills

Education

Any Gradute