2nd Shift QE Records Lead: Deviations & CAPA

Vertex Pharmaceuticals; Boston (MA); On-site; USD 47,000 - 92,000; Full time

Job summary

Vertex Pharmaceuticals in Boston is seeking a 2nd shift staff member to own and execute quality records, including deviations, CAPAs, and change controls, supporting cell manufacturing. The role emphasizes investigations, root-cause analysis, and technical writing with close collaboration across QE and QA teams.

The candidate will follow MTO Engineering Operations practices, with on-site work and varied shift timing per hiring manager.

Qualifications

• This role requires experience with investigations and deviation triage in a GMP environment.
• Strong data review, root cause analysis, and technical writing skills are essential.
• Experience coordinating with SMEs and managing CAPAs and change controls.

Responsibilities

• Own and execute QE records including deviations, CAPAs, and change controls.
• Lead investigations for manufacturing, QC, materials, facility, and equipment deviations.
• Collaborate with SMEs to determine root cause and corrective actions.
• Manage eQMS timelines and escalate as needed.
• Track deliverables in Smartsheet and support QA-aligned practices.

Skills

Deviations handling

CAPA management

Change controls

Root cause analysis

Education

Engineering degree

Relevant degree

Tools

eQMS

Smartsheet

GEMBA

Job description

Vertex Pharmaceuticals in Boston is seeking a 2nd shift staff member to own and execute quality records, including deviations, CAPAs, and change controls, supporting cell manufacturing. The role emphasizes investigations, root-cause analysis, and technical writing with close collaboration across QE and QA teams.

The candidate will follow MTO Engineering Operations practices, with on-site work and varied shift timing per hiring manager.