Quality Records & CAPA Execution Specialist

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

Job summary

Vertex Pharmaceuticals in Boston is seeking a QA Records Specialist on the MTO to own and execute quality records (deviations, CAPAs, change controls) and investigations across manufacturing, QC, and facilities. This on-site role emphasizes data review, root cause analysis, GEMBA, and project management, with collaboration across QA and operations.

The position follows MTO Engineering Operations ways of working and QA best practices, with a defined shift (Sun-Thu 8:00–16:30 or Tue-Sat

Qualifications

• Experience with deviations, CAPAs, and change controls in pharma.
• Strong root cause analysis and technical writing skills.
• Experience with investigations and GEMBA preferred.
• Ability to manage QA records and project timelines.

Responsibilities

• Own deviations triage and investigative planning.
• Lead manufacturing, QC, material, and facility deviation investigations.
• Write quality events using root cause analysis tools.
• Drive CAPAs and change controls end-to-end.
• Maintain QE records in eQMS and track due dates.
• Collaborate with SMEs and escalate as needed.
• Support QA and MTO compliance practices.
• Track deliverables in Smartsheet.

Skills

Deviations handling

CAPA management

Change controls

Root cause analysis

GEMBA

Technical writing

Project management

Data review

Education

Engineering degree

Tools

Smartsheet

eQMS

Job description

Vertex Pharmaceuticals in Boston is seeking a QA Records Specialist on the MTO to own and execute quality records (deviations, CAPAs, change controls) and investigations across manufacturing, QC, and facilities. This on-site role emphasizes data review, root cause analysis, GEMBA, and project management, with collaboration across QA and operations.

The position follows MTO Engineering Operations ways of working and QA best practices, with a defined shift (Sun-Thu 8:00–16:30 or Tue-Sat