Quality Control Investigation/Deviation (2nd Shift)

JMD Technologies Inc.; Boston (MA); On-site; USD 125,000 - 185,000; Full time

Job summary

JMD Technologies Inc. is seeking a senior QA engineer to own and execute quality records including deviations, CAPAs, and change controls in a GMP environment. The role emphasizes investigations, GEMBA, and cross-functional collaboration to ensure compliant manufacturing operations.

Responsibilities include leading root cause analyses, driving corrective and preventive actions, and maintaining eQMS records while aligning with QA and MTO standards. A fast-paced environment experience is required.

Qualifications

• 10+ years in engineering, project mgmt and pharma.
• Experience in fast-paced environments.
• Expert-level experience required.

Responsibilities

• Quality Event & Deviation Management: Support deviation triage with investigational planning and event initiation.
• CAPA & Change Control: Drive CAPAs and change controls from initiation to closure.
• Project Management & Compliance: Track deliverables and ensure timelines; support QA-led initiatives.
• Interviews & GEMBA: Conduct interviews and root-cause analyses to document findings.

Skills

Quality event management

Root cause analysis

GEMBA

Project management

Education

Any Degree

Job description

This senior-level role is responsible for ownership and execution of quality records, including Deviations, CAPAs, Change Controls, and Analytical and Quality Control Investigations supporting cell manufacturing. The role includes data review, interviews, root cause analysis, GEMBA, project management, collaboration, and communication while following MTO Engineering Operations and QA-aligned best practices.

Key Responsibilities

Quality Event & Deviation Management

• Support deviation triage, including coordination, investigational planning, and event initiation
• Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments
• Lead investigations for manufacturing, QC, material, facility, and equipment deviations
• Conduct interviews and GEMBA using root cause analysis tools
• Use root cause analysis tools to lead and write quality events across cell manufacturing, quality control, material operations, and facility operations

CAPA & Change Control

• Collaborate with subject matter experts 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 through execution and closure
• Actively own and drive QE records, including deviations, CAPA, Effectiveness Checks, and change controls, in an electronic Quality Management System (eQMS)
• Ensure all timelines and due dates are achieved

Project Management & Compliance

• Promote MTO- and QA-aligned compliance best practices established by MTO and QA leadership
• Track deliverables and provide timely escalations using Smartsheet
• Support other duties and projects as assigned to meet departmental requirements and manufacturing timelines

Qualifications

• Any Degree with 10+ years of engineering, project management, and pharmaceutical experience
• Expert-level experience
• Experience working in a fast-paced environment