Responsibilities

• Handling quality issues, perform and involve in failure investigation, NCMR, deviation, CAPA, and field return etc. within the Master Control system.
• Review and update Quality documentation (Quality Control Plan, Manufacturing Instruction & Others) as necessary.
• Track, trend and analyze in-process and lot qualification test data (functional, packaging, etc.).
• Analyzing state of system in Quality Operations and participate in process /workflow improvements based on Quality Operations day-to-day activities.
• Assists in developing tools / dashboard for evaluating / monitoring testing & product performance.
• Assists in identifying potential quality problems.
• Support Quality Operations Engineer in coordinating microbiology testing and environmental monitoring testing.
• Support in Quality Operations related administrative activities as required.
• Performs other duties as require...