Manufacturing Investigation Specialist

JMD Technologies Inc.; Boston (MA); On-site; USD 69,000 - 90,000; Full time

Job summary

JMD Technologies Inc. in Boston, MA is seeking a Manufacturing Investigations Staff for the 2nd shift on a 12+ month contract. The role focuses on leading quality records and investigations to support pharmaceuticals manufacturing.

You will manage deviations, CAPAs, Change Controls, and related GMP investigations, perform root cause analysis, and drive corrective actions from initiation to closure.

Qualifications

• Experience in quality events management, deviations, CAPAs, Change Controls, and investigations.
• Experience performing root cause analysis and implementing corrective actions.
• Experience in pharmaceutical/biopharmaceutical GMP manufacturing.

Responsibilities

• Lead and execute Deviations, CAPAs, Change Controls, and QC/Analytical Investigations.
• Lead deviation triage, investigation planning, event initiation, and impact assessments.
• Investigate across Manufacturing, QC, Materials, Facilities, and Equipment operations.
• Conduct SME interviews, GEMBA, data review, and root cause analysis.
• Lead and document root cause investigations and recommend corrective actions.
• Own CAPAs and Change Controls from initiation to closure.

Skills

5+ years experience

Quality event management

Root cause analysis

GMP / regulatory

CAPA / Change Control

Job description

ROLE: Manufacturing Investigations Staff (2nd Shift)

LENGTH: 12+ Months

LOCATION: ONSITE in Boston, MA

SHIFT: 2nd Shift

Responsibilities

• Lead/Own and execute quality records including Deviations, CAPAs, Change Controls, andQC/Analytical Investigations supporting pharmaceuticals manufacturing.
• Lead deviation triage, investigation planning, event initiation, and initial impact assessments.
• Conduct investigations across Manufacturing, QC, Materials, Facilities, and Equipment operations.
• Perform SME interviews, GEMBA activities, data review, and root cause analysis.
• Lead and document root cause investigations and recommend appropriate corrective and preventive actions.
• Own CAPAs and Change Controls from initiation through execution and closure.

Required

• 5+ years of engineering, project management, pharmaceutical, or related industry experience for senior-level candidates.
• Strong experience with quality event management, deviations, CAPA, Change Controls, and investigations.
• Experience performing root cause analysis and developing corrective/preventive actions.
• Experience working in pharmaceutical/biopharmaceutical manufacturing or a regulated GMP environment.

Target Pay Rate: $50–$65/HR

Final rate within this range will be based on skills, experience, and interview results.