Packaging Associate II 1st Shift

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adhere to and enforce GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods)
• Review documentation and verify component attributes
• Ensure compliance during the packaging process by understanding process steps within the packaging record
• Absorb and assist with the overall efficiency of the production within the assigned room or rooms
• Inspect units for quality as they are packaged
• Perform quality inspections as required per the packaging record and per AQL requirements
• Verify the accuracy, completeness, and supported documentation of the packaging requirements outlined in the Batch Record
• Conduct pre-start equipment room check and area clearance pages
• Review pre-post production pages
• Inspect pre-packaging steps
• Verify equipment verification pages and startup verification pages
• Conduct equipment challenges and in-process inspections
• Collect and review quality samples
• Conduct reconciliation checks
• Review and verify product/component transactions, waste logs, and TOR logs as applicable

QUALIFICATIONS

• High School Diploma or GED required
• Some college education desired
• Knowledge of FDA regulations related to cGMP is desired
• Prior experience within a manufacturing or alike assembly process preferred
• Good documentation and communication skills are required
• General knowledge of quality control processes is desired
• Highly attuned and focused on attention to detail is required
• Good organizational and planning skills are required
• Successful completion of the Quality@Source (Q@S) training assessment for the Quality In-Process Inspections as assigned to this position