GMP QA Senior Specialist – 1st Shift (On‑Site)

Vertex Pharmaceuticals LLC

Boston (MA)

On-site

USD 83,000 - 90,000

Full time

14 days+

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Job summary

Vertex Pharmaceuticals LLC seeks a Senior Quality Specialist (1st Shift) in Boston to serve as an expert in quality assurance and compliance. Responsibilities include coordinating GMP activities across clinical and commercial Drug Product manufacturing and disposition, reviewing data, approving CoAs, and guiding product release.

The role is on-site, four days per week, with overtime eligibility and a temporary agency assignment.

Qualifications

Demonstrated success by independently leading cross-functional teams.
Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
Experience leading event investigations, Root Cause Analysis and CAPA; familiarity with Oracle or Veeva systems.
Master’s degree with 2-3 years of relevant work experience, or bachelor’s degree with 5+ years of relevant background.

Responsibilities

Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
Approve CoAs, generate BSE/TSE statements and product labelling.
Archive batch records and documents in eDMS.
Provide QA support for product release and disposition decisions; support quality investigations and issues.