Senior GMP QA Specialist – 2nd Shift

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

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a Senior Quality Specialist (2nd Shift) to lead QA activities ensuring GMP compliance for clinical and commercial Drug Product manufacturing and disposition. The role covers review of batch data, approvals of CoAs, labeling, change controls, CAPAs, and support for inspections, with a focus on timely resolution of quality issues.

Candidates should have a Master’s degree with 2-3 years (or Bachelor’s with 5+ years) in a scientific field and

Qualifications

• Experience leading cross-functional QA teams.
• QA support and oversight of GMP manufacturing including equipment/facilities qualification.
• Experience leading investigations and CAPA.
• Experience with Oracle/Veeva and network-based applications.

Responsibilities

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Approval of CoAs, generating BSE/TSE statement and product labelling.
• Archival of batch records and other supporting documents in eDMS.
• Provide QA support for product release and disposition decisions including handling quality investigations and issues.
• Review and approval of Manufacturing documents.
• Support change controls, GMP investigations and CAPAs.
• Participate in QA walkthroughs and drive closure of audit observations.
• Identify risks and communicate gaps for GMP processes and systems.

Skills

QA oversight

GMP manufacturing

Root Cause Analysis

CAPA

Change control

Documentation review

Oracle

Veeva

Education

Master's degree + 2-3 years

Bachelor's degree in science + 5+ years

Tools

Oracle

Veeva

eDMS

Job description

Vertex Pharmaceuticals LLC in Boston, MA is seeking a Senior Quality Specialist (2nd Shift) to lead QA activities ensuring GMP compliance for clinical and commercial Drug Product manufacturing and disposition. The role covers review of batch data, approvals of CoAs, labeling, change controls, CAPAs, and support for inspections, with a focus on timely resolution of quality issues.

Candidates should have a Master’s degree with 2-3 years (or Bachelor’s with 5+ years) in a scientific field and