JOB DESCRIPTION



ESSENTIAL FUNCTIONS:

• Perform post-batch activities in a timely manner, efficiently, and with accuracy, including but not limited to the following:
  • Ensure all manufacturing documentation is filled out as required, manufacturing packet is complete, and expediently addressing gaps in data and/or documentation when they arise during post-batch review process.
  • Review of manufacturing data/settings for potential issues and enter manufacturing data into corresponding spreadsheets and/or databases.
    
    
  • Scan and index manufacturing packets and records into company document database.
  • End production orders (batch runs) in company ERP system and notify internal teams to address any discrepancies in the ERP system preventing production order from being "Ended" in the system.
• Lead and conduct objective root cause analysis for internal quality issues as they relate to manufacturing data and/or documentation.
• Provide on-site technical and Quality assistance to internal departments, as required, including but not limited to:
  • Customer concerns (root cause analysis, testing, and reporting)
  • Internal corrective action requests (root cause analysis and corrective actions)
  • Internal audits (cross departmental and risk-based auditing)
  • Continuous improvement projects.
• Ensure TCI procedures - Quality Manual, work instructions, forms, flowcharts - and other related documents are maintained, current and up to date.
• Ensure compliance with all training, procedures, record keeping, and documentation requirements supporting TCI's Quality Management System.
• Prepare communications, reports, and give technical presentations.
• Support and/or cover QA team responsibilities during team member absences to ensure process continuity.
• Ensure and maintain a safe working environment for all employees.
• Other duties as assigned.