Pharma Label Control & Packaging Lead

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

Benefits offered by this job

Pay range $75,000- $90,000

Yearly bonus eligibility

Medical, dental and vision coverage

Job summary

Nivagen Pharmaceuticals, Inc. seeks a QA Supervisor to oversee the label control and packaging QA processes.

You will supervise the packaging team, ensure labeling accuracy in SAP, and coordinate with warehouse, customer service, and manufacturing for incoming goods and components. The role requires 3+ years in a pharmaceutical setting, experience with labelling and packaging components, and strong documentation discipline.

Qualifications

• FDA 21Part210/211 knowledge required.
• Quality inspection experience in labelling/components/final product inspection required.
• Pharmaceutical environment experience required (3 years minimum).
• Self-motivated and proactive in preparing documentation and testing products.

Responsibilities

• Manage the Label Control Program ensuring finished product labeling aligns with versions and timelines.
• Oversee Packaging Component Specification program by obtaining documentation from managers, engineers or purchasing.
• Prepare or review change controls to introduce product/components into Nivagen Quality System.
• Develop quality inspection criteria for finished products including label review and temperature requirements.
• Create documentation for QA inspection of each packaging component against supplier drawings and testing.
• Work with Engineer and Operations for component acceptability testing and writing specifications for approval.
• Sample and inspect incoming drug products/components against quality standards and review documentation.
• Maintain initial and final documentation in electronic management system.
• Disposition of product/component after quality review of inspection criteria.
• Set up metadata in SAP of new drug products and establish workflows for inspection criteria.

Skills

FDA 21Part210/211 knowledge

Quality inspection experience

Pharmaceutical environment experience

Self-motivated

Documentation & testing

Job description

Nivagen Pharmaceuticals, Inc. seeks a QA Supervisor to oversee the label control and packaging QA processes.

You will supervise the packaging team, ensure labeling accuracy in SAP, and coordinate with warehouse, customer service, and manufacturing for incoming goods and components. The role requires 3+ years in a pharmaceutical setting, experience with labelling and packaging components, and strong documentation discipline.