Senior GMP QA Ops: Packaging & Labeling Expert

Vertex Pharmaceuticals LLC; Boston (MA); Sur place; USD 76 000 - 103 000; Plein temps

Résumé du poste

The Sr. Specialist GMP QA Operations at Vertex Pharmaceuticals LLC will work independently to oversee quality initiatives in GMP packaging/labeling, batch review and release, and external vendor oversight in a commercial drug environment.

Responsibilities include leading investigations, root cause analysis, CAPA, change controls, and continuous improvement efforts, while collaborating with cross-functional teams and ensuring regulatory compliance.

Qualifications

• Bachelor's degree in a scientific or allied health field is required.
• Experience in batch release, GMP environment, or equivalent is required.
• Experience supporting multiple projects and cross-functional teams is expected.

Responsabilités

• Master and executed batch record review and resolution of comments/issues.
• Archiving batch documents in electronic document system.
• Track data for metrics generation.
• Evaluate Investigations/OOS/Change Controls to support Disposition Status.
• Disposition decision and status change in Oracle.
• Provide quality oversight for root-cause analysis and product impact assessment.
• Support change control assessments, implementation and closure.
• Identify and facilitate continuous improvement efforts.
• Draft and revise Quality Agreements between CMOs/Suppliers and Vertex as needed.
• Represent Vertex Quality on cross-functional teams and drive CAPA actions.
• Support continuous improvement projects.

Connaissances

Batch release

GMP knowledge

Quality systems

Root Cause Analysis

CAPA

Cross-functional collaboration

Investigations

Change controls

Quality oversight

Problem solving

Formation

Bachelor's degree in scientific or allied health field

Outils

Oracle

Description du poste

The Sr. Specialist GMP QA Operations at Vertex Pharmaceuticals LLC will work independently to oversee quality initiatives in GMP packaging/labeling, batch review and release, and external vendor oversight in a commercial drug environment.

Responsibilities include leading investigations, root cause analysis, CAPA, change controls, and continuous improvement efforts, while collaborating with cross-functional teams and ensuring regulatory compliance.