Senior Quality Specialist, GMP & Compliance - 2nd Shift

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 135,000 - 146,000; Full time

Job summary

Vertex Pharmaceuticals LLC seeks a Senior Quality Specialist to lead GMP activities on the 2nd shift for clinical and commercial Drug Product manufacturing and disposition. You will review batch records, approve CoAs, manage quality systems and provide QA guidance on investigations and CAPA, ensuring timely product release and shipment.

The role requires strong cross-functional collaboration, change control support, and assurance of compliance within a fast-paced Biotech environment in the

Qualifications

• Independently lead cross-functional teams.
• GMP manufacturing QA support including equipment, utilities and batch release.
• Lead event investigations, root cause analysis and CAPA with enterprise systems.
• Master’s degree with 2–3 years of relevant experience or a bachelor’s with 5+ years.

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 and support document control.
• Provide QA support for change controls, investigations and CAPAs.
• Assist with audits, risk assessment and site program support.
• Guide product disposition decisions including shipment and release.

Skills

GMP Compliance

Quality Assurance

Cross-functional

CAPA Investigations

QA Documentation

Education

Master’s degree in a scientific field

Bachelor’s degree in a scientific field

Tools

Oracle

Veeva

Job description

Vertex Pharmaceuticals LLC seeks a Senior Quality Specialist to lead GMP activities on the 2nd shift for clinical and commercial Drug Product manufacturing and disposition. You will review batch records, approve CoAs, manage quality systems and provide QA guidance on investigations and CAPA, ensuring timely product release and shipment.

The role requires strong cross-functional collaboration, change control support, and assurance of compliance within a fast-paced Biotech environment in the