Senior GMP QA Analyst - Analytical Excellence

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 76,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a GMP QA Analytical Sr. Quality Specialist to act as a subject matter expert in QA compliance for the Analytical function, supporting clinical and commercial programs from Boston.

The role emphasizes data review, documentation control, and collaboration with internal and external partners. The position involves GMP document reviews, method validation/transfer support, and drafting quality agreements with CMOs.

Qualifications

• Bachelor's degree in a scientific field and relevant QA experience.
• Experience with cGMPs in pharmaceutical settings and regulatory guidelines.
• Hands-on involvement with change control, CAPA and investigations.
• Strong documentation and analytical method understanding.

Responsibilities

• Provides GMP QA review of stability and release data for clinical products.
• Conducts GMP document review: procedures, specs, methods, and reports.
• Supports method validation, verification, and transfer activities.
• Drafts and enforces Quality Agreements with CMOs/Suppliers.
• Oversees change control assessment, implementation and closure; approves investigations.
• Supports root-cause analysis and CAPA actions; maintains quality metrics.
• Represents Analytical QA on cross-functional teams and communicates risks.
• Supports internal and external audits and audit responses.

Skills

cGMP knowledge

Analytical methods

Change controls

CAPA & RCA

Audit support

QA analysis

Education

Bachelor's degree in science

Tools

QDoccs

Trackwise

Veeva

HPLC

Job description

Vertex Pharmaceuticals is seeking a GMP QA Analytical Sr. Quality Specialist to act as a subject matter expert in QA compliance for the Analytical function, supporting clinical and commercial programs from Boston.

The role emphasizes data review, documentation control, and collaboration with internal and external partners. The position involves GMP document reviews, method validation/transfer support, and drafting quality agreements with CMOs.