Chemist

Job Summary

The role of QC Chemist (Trainee – III) is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples, method transfers, and cleaning validations. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties

 JOB DUTIES & RESPONSIBILITIES

• Conduct routine analytical testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation while adhering to cGMP and established policies.
• Conduct analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms.
• Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity), and chemical analytical testing such as dissolution, content uniformity, blend uniformity, Assay, Related compounds, particle size distribution, density, water determination.
• Proficient in operating the laboratory instrumentation/equipment, including but not limited to:, FTIR, HPLC, UPLC, Dissolution apparatus, ICP-MS, GC, UV-Vis, Karl fisher (KF), Ion chromatography (IC), Malvern Master sizer, etc.
• Complete documentation needed to support testing procedures including test forms and logbooks.
• Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.
• Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations.
• Perform the Calibration, Qualification, Preventive maintenance, and routine trouble shooting of analytical instruments like UPLC, HPLC, IC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto titrator, FT-IR Spectrophotometer and Polarimeter 
• Assist other chemists with trouble shooting of general laboratory instrumentation, analyses, and methodologies.
• Prepare and review of stability summary reports, Investigation, technical reports and analytical methods. 

Education & Experience

• BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Biotechnology or related field 
• Must be knowledgeable of laboratory instrumentation/equipment, including but not limited to: FTIR, HPLC, UPLC, Dissolution apparatus, ICP-MS, GC, UV-Vis, Karl fisher (KF), Ion chromatography (IC), Malvern Master sizer, etc.