QA Technician II

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.
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