Senior GMP QA & Compliance Specialist - 2nd Shift

Vertex Pharmaceuticals; Boston (MA); On-site; USD 90,000 - 96,000; Full time

Job summary

Vertex Pharmaceuticals seeks a Senior Quality Specialist (2nd Shift) to lead QA and GMP activities for clinical and commercial Drug Product manufacturing and disposition.

The role supports batch release, investigations, CAPAs, change controls, and audits on the 2nd shift (Sun-Wed, 12:30pm–11:00pm EST), with responsibilities on CoA approvals, material release, and documentation in eDMS.

Qualifications

• Leading cross-functional teams in QA and GMP operations.
• Experience with GMP manufacturing oversight, equipment and facilities qualification.
• Experience with root cause analysis and CAPA; familiarity with Oracle/Veeva.

Responsibilities

• Review batch data, deviations, in-process data and QC release testing.
• Approve CoAs, generate BSE/TSE statements and product labelling.
• Archive batch records in electronic DMS (eDMS).
• Provide QA support for product release and disposition decisions.
• Review and approve Manufacturing documents.
• Release raw materials and equipment/area clearance.
• Support change controls, GMP investigations and CAPAs.
• Assist with audits and closure of observations.
• Identify GMP risks and drive process improvements.
• Support inspection readiness and quality process optimization.

Skills

GMP knowledge

QA oversight

Root cause analysis

CAPA management

Change control

Documentation

GxP compliance

Education

Master’s degree

Bachelor’s degree

Tools

Oracle

Veeva

Job description

Vertex Pharmaceuticals seeks a Senior Quality Specialist (2nd Shift) to lead QA and GMP activities for clinical and commercial Drug Product manufacturing and disposition.

The role supports batch release, investigations, CAPAs, change controls, and audits on the 2nd shift (Sun-Wed, 12:30pm–11:00pm EST), with responsibilities on CoA approvals, material release, and documentation in eDMS.