QE Execution Lead - 2nd Shift, Quality Records

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

Job summary

Vertex Pharmaceuticals LLC in Boston is seeking a 2nd shift staff member for MTO to own and execute quality records including deviations, CAPAs, Change Controls, and Investigations across cell manufacturing. This on-site role emphasizes QA-aligned best practices, data review, interviews, root cause analysis, GEMBA, and collaboration with SMEs.

Shift: 2nd shift M-F 1:00pm - 9:00pm; ideal candidate has experience with investigations, root cause analysis, technical writing, validation and deviation

Qualifications

• Senior Level: Any Degree with 5+ years engineer, project management, pharmaceutical experience.
• Mid-Level: Engineering or Relevant Degree with 2-5 years' work experience.
• Junior Level: Engineering Degree with 0-1 year experience.

Responsibilities

• Involved in deviation triage including coordination and investigational planning and event initiation.
• Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments.
• Lead investigation for manufacturing, QC, material, facility and equipment deviations including interviews, GEMBA using root cause analysis tools.
• Use root cause analysis tools to lead and write quality events in cell manufacturing, quality control, material operations and facility operations functional areas.
• Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.
• Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure.
• Actively own and drive QE records (deviations, CAPA, Effectiveness Check, change control) in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
• Promote MTO and QA- aligned compliance best practices established by MTO and QA leadership.
• Tracking of deliverables and timely escalations in MTO project management tool (Smartsheet).
• Other duties and projects as assigned to meet departmental requirements and manufacturing timelines.

Skills

Quality Records

Investigations

Root Cause Analysis

GEMBA

Technical Writing

Education

Engineering or Related Degree

Tools

Smartsheet

eQMS

CAPA Tools

Job description

Vertex Pharmaceuticals LLC in Boston is seeking a 2nd shift staff member for MTO to own and execute quality records including deviations, CAPAs, Change Controls, and Investigations across cell manufacturing. This on-site role emphasizes QA-aligned best practices, data review, interviews, root cause analysis, GEMBA, and collaboration with SMEs.

Shift: 2nd shift M-F 1:00pm - 9:00pm; ideal candidate has experience with investigations, root cause analysis, technical writing, validation and deviation