On-Floor QA Lead - GMP & Batch Release

Actalent; Sanford (NC); Sur place; USD 52 000 - 58 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Plan

Life Insurance

PTO / Vacation

Sick Leave

Résumé du poste

Actalent in Sanford, NC seeks a Quality Assurance Operations Specialist II to launch and lead QA systems for a monoclonal antibody facility. The role blends GMP readiness, tech transfer, and licensure activities, ensuring global GxP compliance across site operations.

You will perform batch record reviews, QA oversight on the floor, CAPA handling, deviations, and change controls within Veeva, while fostering a culture of quality from construction through operation.

Qualifications

• Advanced Quality Assurance expertise.
• Experience in batch record review and GMP.
• Capability in QA - On the Floor QA, Batch Release, and Batch Disposition.
• Proficiency in CAPA and Investigations.

Responsabilités

• Execute QA activities including batch record review and QA oversight of warehouse and incoming quality.
• Collaborate cross-functionally to monitor site quality metrics and investigate deviations.
• Lead regulatory readiness activities and ensure GxP compliance across operations.
• Participate in regulatory inspections and drive quality culture initiatives.
• Lead investigations of non-conformances and drive CAPA actions.

Connaissances

Advanced QA

Batch record review

GMP

On-the-Floor QA

Batch Release

Batch Disposition

CAPA investigations

Outils

Veeva Quality Management System

Description du poste

Actalent in Sanford, NC seeks a Quality Assurance Operations Specialist II to launch and lead QA systems for a monoclonal antibody facility. The role blends GMP readiness, tech transfer, and licensure activities, ensuring global GxP compliance across site operations.

You will perform batch record reviews, QA oversight on the floor, CAPA handling, deviations, and change controls within Veeva, while fostering a culture of quality from construction through operation.