QC Analyst II

Role Summary:

Reporting to the Quality Control Manager the QC Analyst II is responsible for the analysis of raw materials, in-process, finished products and stability samples using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOPs and Bimeda quality standards. This position also provides testing support for the Stability Program. Quality Control Analyst II is experienced with all types of laboratory equipment and can troubleshoot common instrumentation issues and provide guidance to junior QC Analysts and Technicians.

Key Role Specific Requirements

Key Responsibilities:

• Conducts all analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases, water, and stability program samples. i.e., pH, conductivity, TOC, viscosity, potency tests • Reviews data, results, and documentation for QC analytical testing. • Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP), and Standard Operating Procedures (SOPs). • Prepares samples for analysis according to company methods, SOPs, & applicable compendia (USP/EP). • Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF, and other instruments. • Documents analytical test results as they occur in logbooks and in-process test data in production dockets as required. • Analyzes data; keeping the supervisor informed of discrepancies, deviations, out-of-specifications (OOS) data…