Reagent Fill Technician III

Responsibilities

• Handling and transporting of temperature-sensitive (semi-)finished goods for use in blood typing kits
• Perform in-process visual inspection of temperature-sensitive (semi-)finished goods for use in blood typing kits as they come off the fill line before placement in trays
• Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood typing kits for QC and Bio-burden
• Receives and verifies the accuracy of materials transferred from the warehouse
• Assists with material handling, folding product boxes/trays, and staging of materials for process orders
• Understands and executes written procedures in accordance with cGMP
• Performs labor transactions in the Enterprise Resource Planning (ERP) System
• Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review
• General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash
• Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances
• Maintains accurate and complete training records
• Maintains and archives Manufacturing log sheet records
• Demonstrate processes during audits, including ISO, FDA and internal audits
• Follows all safety rules
• Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines
• Verify or perform cycle counts and verify discrepancy, conduct investigation, and complete report to notify lead
• Independently perform and lead the set-up and operation of reagent filling equipment of at least 70% of automated fill machines
• Perform equipment troubleshooting during operation to ensure completion within the scheduled time frame
• Assist with training and mentoring Reagent Fill Technicians I and Reagent Fill Technicians II
• Primary contact for material transfer delegation
• Participate in the execution of process improvement projects
• Implement new areas or ideas for 5S
• Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation

Additional Responsibilities

• Cross-functional communication participation
• Assists packaging crew as needed
• Responsible for flushing water ports and eyewash stations
• Adhere to target manufacturing timelines
• Punctuality and attendance are required
• Attentiveness and openness to learn new processes
• Performs refrigerator/freezer maintenance
• May cross-train in other areas of manufacturing and operations based on business need
• May mentor and help train Reagent Fill Technician I and II
• Absorb and review Device History Records (DHR)
• May be responsible for demonstrating manufacturing processes during a customer or regulatory audit