Lead Label Control & Packaging QA Supervisor

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Yearly bonus

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals is seeking a QA Supervisor to supervise label control and packaging, ensuring accurate labeling and release in SAP and QA systems, and coordinating with warehouse, customer service, and manufacturing.

You will lead the packaging QA team, develop inspection criteria, review documents, and drive compliance with GMP and FDA regulations, including change controls and deviation handling.

Qualifications

• FDA 21 Part 210/211 knowledge is required.
• 3 years minimum experience in pharmaceutical quality assurance.
• Self-motivated and proactive in documentation and testing.

Responsibilities

• Manage the Label Control Program ensuring finished product is correctly labeled in SAP.
• Oversee Packaging Component Specification program and obtain documentation from managers.
• Prepare or review change controls to introduce products/components into Quality System.
• Develop quality inspection criteria for finished products, including label review and testing.
• Create documentation for quality inspection of packaging components against drawings.
• Collaborate with Engineering and Operations for component acceptability testing and specs.
• Sample and inspect incoming drug products/components and document accurately.
• Maintain initial and final documentation in the electronic management system.
• Disposition of product/components after quality review.
• Set up metadata in SAP for new drug products and establish workflows.
• Investigate non-conformances with Purchasing, write deviations, SCARs.
• Track supplier performance and assist in quality agreements.
• Maintain clean work areas and proper labeling; ensure timely release for production.

Skills

Leadership

QA oversight

Attention to detail

Tools

SAP

TrackWise

Job description

Nivagen Pharmaceuticals is seeking a QA Supervisor to supervise label control and packaging, ensuring accurate labeling and release in SAP and QA systems, and coordinating with warehouse, customer service, and manufacturing.

You will lead the packaging QA team, develop inspection criteria, review documents, and drive compliance with GMP and FDA regulations, including change controls and deviation handling.