QA CTO Label Specialist
Location: Summit, NJ (100% Onsite)
Schedule: Wed–Sat | 6:30 AM – 4:30 PM
Pay Rate: $34.97/hr (W2)
Seeking a skilled QA Label Specialist to support label control operations within their S-12 Cell Therapy Manufacturing facility. This role ensures accurate and compliant issuance of labels for clinical and commercial products while working closely with production and quality teams.
Key Responsibilities:
Issue and verify clinical/commercial in-process and final product labels
Ensure all printed information meets GMP and health authority requirements
Coordinate label issuance with manufacturing teams
Write, review, and update SOPs
Support deviations, CAPA, change controls, and investigations
Assist during internal audits and regulatory inspections
Maintain adherence to GMP, quality, and compliance standards
Must-Have Experience:
GMP & Quality Compliance background
Experience with deviations, CAPA, investigations
Strong SOP writing skills
Pharma/biotech experience
Good documentation and project coordination skills
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Requirements
GMP & Quality Compliance background
Experience with deviations, CAPA, investigations
Strong SOP writing skills
Pharma/biotech experience
Good documentation and project coordination skills
Additional Instructions
Issue and verify clinical/commercial in-process and final product labels
Ensure all printed information meets GMP and health authority requirements
Coordinate label issuance with manufacturing teams
Write, review, and update SOPs
Support deviations, CAPA, change controls, and investigations
Assist during internal audits and regulatory inspections
Maintain adherence to GMP, quality, and compliance standards
