Responsibilities:

• Will perform Analytical testing
• Under supervision, performs testing, conducts lab investigations, problem-solves, and reports aberrant results to management.
• Performs biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolalilty
• Ensures testing and release time lines are met.
• Follows well-defined and established procedures and best practices.
• Reviews QC test results Documentation
• Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
• Prepares sample reconciliation reports and other reports as needed.
• Assists with QC's data management, including data review and control charting.
• Process improvement and compliance
• Coordinates and manages continuous improvement projects
• Revises standard operating procedures, training manuals, etc which are submitted to management for review and final approval.
• Maintains specific QC files and database records for process and/or quality improvement efforts.
• Manages and maintains deviation and change control records.
• Experience with UV-vis absorbance, gel electrophoresis, pH, Osmolalilty
• GMP experience is highly preferred
• Drug product device testing