Job Details

KNOWLEDGE

• Be familiar with equipment safety requirements
• Be familiar with evacuation and shelter in place processes
• Be familiar with PPE requirements
• Begin learning processes via hands on practice and SOP instruction from the department training matrix
• cGMP awareness and compliance
• GDP awareness and compliance
• Read complete batch record
• Prepare tank and hookups for packaging production
• Perform line tasks as instructed
• Record process information in packaging records and logbooks
• Clean equipment and workspaces
• Familiar with use of packaging line equipment
• Perform all duties following company safety procedures
• Accountable for accurate packaging of products free from contamination in accordance with FDA cGMP requirements
• Setup filler
• Correctly document downtime in batch record
• Operate material handling equipment
• Review completed batch records for accuracy
• Available for cross-training opportunities

• Complete task list
• Complete written assessment
• Management or supervisor sign-off

• General supervision and instructions are given for routine work and detailed instructions given for new assignments

• Lean Manufacturing