Job description
Position Summary
The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner.
Responsibilities:
Responsibilities:
The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks.
AQL inspections, reworks and Material reconciliation that goes along with the batch.
Primary Duties
Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces.
Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.
Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner.
Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.
Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns.
Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements.
Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
Perform self-audit of rooms and processes.
Train and certify teammates on production processes and procedures.
Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making.
Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
Perform computer applications.
Perform all work in compliance with company quality procedures and standards.
Performs other duties as assigned.