QE Execution Staff, Manufacturing Technical Operations (contract) 804

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

Job summary

Vertex Pharmaceuticals LLC is seeking a staff member for the MTO Engineering Operations in Boston to own and execute quality records such as deviations, CAPAs, change controls, and investigations across manufacturing and QC functions.

The role emphasizes data review, root cause analysis, GEMBA, project management, and collaboration with SMEs, with shifts based on the hiring manager. This is an on-site position in Boston.

Qualifications

• Senior level requires engineering degree with 5+ years in engineering, project management and pharmaceutical experience.
• Mid level requires engineering degree with 2-5 years' work experience in industry.
• Junior level requires engineering degree with 0-1 year experience and eagerness to learn.

Responsibilities

• Involved in deviation triage including coordination and investigational planning and event initiation.
• Lead investigations for manufacturing, QC, material, facility and equipment deviations using root cause analysis tools.
• Own and drive CAPAs, change controls and QE records in eQMS, ensuring timelines and due dates are met.
• Collaborate with SMEs to determine root cause and propose corrective and preventive actions.

Skills

Project management

Pharma experience

Education

Engineering degree

Job description

Job Description

This staff member on the MTO is responsible for ownership and execution of quality records including, Deviations, CAPAs, Change Controls, and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of QE execution including data review, interviews, root cause analysis, GEMBA, project management, excellent collaboration, and communication.

This execution-focused role will follow the MTO Engineering Operations ways of working, and QA aligned best-practices to efficiently and effectively execute records through completion. This role is an on-site position based in our Boston and has a defined shift depending on the hiring manager.

*** The ideal candidate will have experience with investigations, root cause analysis, technical writing, validation and deviation triaging ***

Shifts:

Sunday-Thursday: 8:00am - 4:30pm

Tuesday - Saturday: 8:00am - 4:30pm

KEY 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.

QUALIFICATIONS:

• Senior Level: Any Degree with 5+ years engineer, project management, pharmaceutical experience - Experienced in fast-paced environment
• Mid-Level: Engineering or Relevant Degree with 2-5 years' work experience - Some experience in industry desired
• Junior Level: Engineering Degree with 0-1 year experience - Eager to learn about the industry

Pay Range

Jr: $34-$38/hr

Mid: $48-$53/hr

Sr: $63-$67/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

No C2C or Third-Party Vendors