GMP Quality Floor Lead - Cell Therapy Manufacturing

Vertex Pharmaceuticals LLC; Boston (MA); Vor Ort; USD 90.000 - 96.000; Vollzeit

Zusammenfassung

Vertex Pharmaceuticals is seeking a Quality Shop Floor Specialist to oversee floor quality for autologous cell and gene therapy production in a cGMP cleanroom. You will support batch records review, disposition, and ensure compliance with policy, procedures, and regulations.

The role requires strong collaboration with cross-functional teams, root-cause analysis, CAPA actions, data collection, and training. GMP practices and experience with electronic QA systems are preferred.

Qualifikationen

• Bachelor's degree in scientific or allied health field.
• Solid understanding of cGMPs in pharmaceutical setting.
• Experience leading projects or teams to deadlines.
• Strong written and verbal communication for cross-functional teams.

Aufgaben

• Support manufacturing activities for cGMP compliance and guide QA issues.
• Review batch records and perform product disposition.
• Collaborate with partners to resolve quality issues and implement compliant solutions.
• Lead root-cause analysis and CAPA actions for deviations, OOS, OOT.
• Train employees and support continuous improvement activities.

Kenntnisse

cGMPs knowledge

Project leadership

Cross-functional communication

Workload management

Written and verbal communication

Team player

Root Cause Analysis

CAPA experience

Ausbildung

Bachelor's degree in science or allied health

Tools

QDoccs

Trackwise

Veeva

Jobbeschreibung

Vertex Pharmaceuticals is seeking a Quality Shop Floor Specialist to oversee floor quality for autologous cell and gene therapy production in a cGMP cleanroom. You will support batch records review, disposition, and ensure compliance with policy, procedures, and regulations.

The role requires strong collaboration with cross-functional teams, root-cause analysis, CAPA actions, data collection, and training. GMP practices and experience with electronic QA systems are preferred.