Quality Packaging Associate II - 3rd Shift

Essential Duties And Responsibilities

• Adhere to and enforce GMP compliance, perform quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods)
• Review and understand process steps within the packaging record to ensure compliance during the packaging process
• 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 below and ensure all are supported by the appropriate documentation within the Batch Record
• Conduct pre-start equipment room check and area clearance pages
• Complete pre-post production pages
• Execute pre-packaging steps
• Verify equipment startup verification pages
• Conduct equipment and component startup verifications
• Handle equipment challenges and in-process inspections
• Collect and review quality samples
• Conduct reconciliations and check weigher sheets
• Manage product/component transactions and waste logs
• Manage TOR logs as applicable

Qualifications

High school diploma or equivalent required. Bachelor's degree preferred.

Skills

• Strong attention to detail
• Ability to work independently and as part of a team
• Knowledge of GMP compliance and quality assurance procedures
• Proficiency in reading and understanding process steps within packaging records
• Experience with equipment verification and startup procedures
• Basic computer skills including Microsoft Office

Benefits

Comprehensive health insurance coverage

Flexible spending accounts

Retirement savings plan

Employee assistance program

Professional development opportunities

Pay

Competitive salary based on experience

Schedule

Full-time position