GMP Labeling & Packaging QA Supervisor

Nivagen Pharmaceuticals Inc; Sacramento (CA); Sur place; USD 75 000 - 90 000; Plein temps

Avantages offerts par ce poste

Yearly bonus eligibility

Medical, dental, vision coverage

Paid time off

Résumé du poste

Nivagen Pharmaceuticals Inc. is seeking a QA Supervisor to oversee label control and packaging QA, ensuring accurate labeling and timely product release. You will work with SAP and TrackWise, coordinate with warehouse and manufacturing, and lead the QA team to uphold quality standards.

The role requires FDA knowledge, 3+ years in pharma QA, and strong documentation skills. Expect GMP audits and active process improvements in packaging QC.

Qualifications

• FDA 21 CFR Part 210/211 knowledge.
• Quality inspection experience in component or final product inspection is required.
• Experience in a pharmaceutical environment is required (3 years minimum).
• Self-motivated and proactive in preparing documentation and testing products.

Responsabilités

• Manage the Label Control Program ensuring correct labeling and release in SAP.
• Oversee Packaging Component Specification documentation and supplier reports.
• Prepare or review change controls for Quality System.
• Develop inspection criteria for finished products including label and temperature checks.
• Create QA documentation for each packaging component against specs and tests.
• Sample and inspect incoming drug products and components against standards.

Connaissances

Quality inspection

Statistical sampling

Documentation

Communication skills

Critical thinking

Self-motivated

Formation

FDA 21 CFR Part 210/211 knowledge

Outils

SAP

TrackWise

Description du poste

Nivagen Pharmaceuticals Inc. is seeking a QA Supervisor to oversee label control and packaging QA, ensuring accurate labeling and timely product release. You will work with SAP and TrackWise, coordinate with warehouse and manufacturing, and lead the QA team to uphold quality standards.

The role requires FDA knowledge, 3+ years in pharma QA, and strong documentation skills. Expect GMP audits and active process improvements in packaging QC.