QC Chemist

Overview

Quality Control Chemistry is responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for cGMP operations. Various techniques are utilized in Quality Control including FT-IR, UV, KF, HPLC and other methods. Additional functions include daily calibration, stability testing, assay transfers, etc., in the Quality Control laboratory.

• The QC Analyst is responsible for performing routine to complex techniques associated with daily QC release and provides an investigative or technological orientation in implementing, executing, and interpreting quality procedures and test methods.
• Perform UV-Vis spectrophotometry, HPLC and Gel assays for in-process and final product samples.
• Perform pH, Karl Fischer, Osmolarity, Rheology analysis in accordance with approved procedure.
• Perform maintenance on complex laboratory equipment including HPLC systems.
• Investigate and troubleshoot Quality Control methods.
• Prepare investigations related to 00S/00T results.
• Review QC Data for compliance to procedures and specifications.
• Prepare statistical analysis of results.
• Identify deviations from QC methods.
• Recommend method improvements.
• Work effectively with others to achieve shared goals.
• Interact with external personnel on technical matters requiring coordination between sites.
• Work independently with minimal supervision and direction.
• Work in compliance with cGMPs.
• Practice safe work habits and adhere to client's safety procedures and guidelines.