Description

You will perform routine analysis of finished products and in-process samples using laboratory instrumentation and techniques.

Responsibilities

• Execute testing for Assay, related substances, Karl Fisher, Dissolution, disintegration, hardness, content uniformity, and blend uniformity.
• Conduct data review, data trending, and laboratory investigations using the TrackWise system.
• Perform stability testing under various ICH conditions and support QC release.
• Maintain high-quality laboratory documentation in accordance with SOPs, cGMPs, and regulatory guidelines.
• Support manufacturing activities through in-process testing and physical evaluation of pharmaceutical products.

Required Skills

• 3 or more years of industry experience in pharmaceutical product development.
• Hands-on expertise with HPLC, GC, UPLC, Dissolution, UV, KF, and FTIR.
• Experience performing wet chemistry testing and physical evaluations.
• Working knowledge of GMP and ICH regulations.
• Experience handling DEA controlled substances.
• Proficiency in data management and maintaining laboratory documentation.
• Ability to develop and execute complex procedures or methods.

Preferred Skills

• Master of Science in Analytical Chemistry or Pharmaceutics.

Key Skills

Education

Bachelor's Degree