"Alerted.org

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.