QA Technician II

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.


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* 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.