QE Execution Staff, Manufacturing Technical Operations (contract) 804

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, * 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.

• 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