Pharma Quality Investigator | CAPA & Root Cause

Guerbet; Raleigh (NC); On-site; USD 90,000 - 110,000; Full time

Job summary

Guerbet, a global leader in medical imaging, is hiring a Quality Investigator in Raleigh, NC. You will conduct site-related investigations, identify root causes, and recommend CAPAs with cross-functional teams to ensure regulatory compliance.

The role supports audits, data trending, SOP revisions, and continuous improvement initiatives to protect product and process integrity. Requires a 3–5 year background in a pharmaceutical or FDA-regulated setting and SAP proficiency.

Qualifications

• Bachelor’s degree in chemistry, Microbiology, Biology or Engineering is preferred.
• Other science-related degrees may be considered.
• Actual job experience may be used in lieu of degree.
• Minimum 3-5 years’ experience in a pharmaceutical, biological or other FDA-regulated industry setting is preferred.

Responsibilities

• Investigate and complete site related exceptions minor and major investigations or critical investigations with coaching based on demands of the department.
• Identify root cause and recommend appropriate CAPAs to address root cause.
• Perform Phase II OOS investigations.
• Supports external audits from regulatory agencies and customers (i.e., Document Runner, Documentation Pre-Review, Scribe, etc.).
• Assist in the department in trending of metrics (i.e., Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, Data Trend Analysis).
• Support data compilation for department requirements related to site Annual Product Reviews (APRs).
• Participate as a team member for site Kaizens or brainstorming initiatives to drive continuous improvement.
• Ability to perform SOP revisions as needed.
• Prepare GEMBA plans and perform walks to drive compliance and improve safety at the site.
• Ability to track the performance of assignments through to completion and meet with management on a weekly basis to report progress.

Skills

Root cause analysis

CAPA implementation

SOP revisions

SAP

Education

Bachelor's degree in chemistry

Science degree

Tools

MS Office

Job description

Guerbet, a global leader in medical imaging, is hiring a Quality Investigator in Raleigh, NC. You will conduct site-related investigations, identify root causes, and recommend CAPAs with cross-functional teams to ensure regulatory compliance.

The role supports audits, data trending, SOP revisions, and continuous improvement initiatives to protect product and process integrity. Requires a 3–5 year background in a pharmaceutical or FDA-regulated setting and SAP proficiency.