Senior Quality Systems & Investigations Specialist

JMD Technologies Inc.; Boston (MA); On-site; USD 90,000 - 103,000; Full time

Job summary

JMD Technologies Inc. is seeking a Senior Quality Systems & Investigations Specialist to lead quality investigations and quality-system activities in a fast-paced pharmaceutical manufacturing environment.

You will manage Deviations, CAPAs, Change Controls, and QC Investigations from initiation through closure. The ideal candidate will apply GEMBA methodologies, conduct RCA, and collaborate with cross-functional teams to implement sustainable CAPAs and drive eQMS excellence.

Qualifications

• 10+ years of experience in engineering, project management, pharmaceutical manufacturing, quality, or related field.
• Strong hands-on experience with Deviation Investigations, CAPA, and Change Controls.
• Experience conducting RCA and investigation activities.
• Knowledge of GEMBA walk methodologies.
• Experience with eQMS or electronic quality management systems.

Responsibilities

• Own and execute quality records, including Deviations, CAPAs, Change Controls, and QC Investigations.
• Lead deviation triage, investigation planning, and event initiation.
• Conduct interviews, GEMBA activities, data reviews, and RCA.
• Lead investigations involving manufacturing, quality control, materials, facilities, and equipment.
• Develop and implement corrective and preventive actions.
• Manage CAPAs and Change Controls from initiation through closure.
• Maintain and drive quality records within an eQMS.
• Track investigation milestones, timelines, and escalations with project tracking tools.
• Collaborate with cross-functional teams to identify root causes and sustainable solutions.
• Ensure quality records are completed accurately and on time.

Skills

Deviations, CAPAs, Change Controls

GEMBA / Gemba Walk

Root Cause Analysis (RCA)

Quality Records Management

Cross-functional Collaboration

Education

10+ years experience in pharma/quality

Tools

eQMS

Smartsheet

Job description

Title: Senior Quality Systems & Investigations Specialist

Employment Type: Contract

Duration: 12+ Months

Shift: 2nd Shift

Status: Accepting Candidates

About the Role

We are seeking an experienced Senior Quality Systems & Investigations Specialist to lead and execute quality investigations and quality-system activities within a fast-paced pharmaceutical manufacturing environment. The ideal candidate will have strong experience managing Deviations, CAPAs, Change Controls, and QC Investigations from initiation through closure.

Key Responsibilities

• Own and execute quality records, including Deviations, CAPAs, Change Controls, and QC Investigations.
• Lead deviation triage, investigation planning, and event initiation.
• Conduct interviews, GEMBA activities, data reviews, and Root Cause Analysis (RCA).
• Lead investigations involving manufacturing, quality control, materials, facilities, and equipment.
• Develop and implement effective corrective and preventive actions.
• Manage CAPAs and Change Controls from initiation through closure.
• Maintain and drive quality records within an electronic Quality Management System (eQMS).
• Track investigation deliverables, milestones, timelines, and escalations using project tracking tools.
• Collaborate with cross-functional teams to identify root causes and implement sustainable solutions.
• Ensure quality records are completed accurately and within established timelines.
• Support continuous improvement initiatives in a fast-paced pharmaceutical environment.

Required Qualifications

• 10+ years of experience in engineering, project management, pharmaceutical manufacturing, quality, or a related field.
• Strong hands-on experience with Deviation Investigations, CAPA, and Change Controls.
• Experience conducting Root Cause Analysis (RCA) and investigation activities.
• Knowledge of GEMBA / Gemba Walk methodologies.
• Experience working with eQMS or electronic quality management systems.
• Experience leading cross-functional investigations.
• Strong project management, organizational, analytical, and problem-solving skills.
• Ability to manage multiple quality records, priorities, and deadlines in a fast-paced environment.
• Strong written and verbal communication skills.

Preferred Experience

• Pharmaceutical, biotechnology, or life sciences manufacturing experience.
• Experience with QC investigations and manufacturing quality systems.
• Experience with manufacturing deviations involving equipment, facilities, materials, or processes.
• Experience with Smartsheet or similar project/workflow management tools.
• Experience supporting continuous improvement and quality-system initiatives.

Compensation (MA Pay Transparency):

• Estimated hourly range: $65–$75/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.