GMP Quality Training Specialist

Guerbet; Raleigh (NC); On-site; USD 90,000 - 115,000; Full time

Job summary

Guerbet, a global leader in medical imaging, seeks a Quality Training Specialist in Raleigh, NC to strengthen GMP training, document control, and regulatory compliance.

You will own the site training system, coordinate cross-functional programs, maintain LMS, and support audits and CAPAs. The role requires a science background and experience in regulated environments. Join a collaborative team dedicated to quality, continuous improvement, and patient safety.

Qualifications

• Bachelor’s degree in a scientific, technical, or related discipline (or equivalent experience).
• 2–5+ years of experience in a regulated environment (e.g., pharmaceutical, biotech, medical device).
• Knowledge of cGMP regulations and quality systems requirements.
• Experience supporting training programs, LMS, or compliance training activities.
• Familiarity with Learning Management Systems (LMS) and training documentation practices.
• Strong organizational, communication, and problem‑solving skills.
• Detail‑oriented with the ability to manage multiple priorities in a fast‑paced environment.
• Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint).

Responsibilities

• Act as process owner for the site training system (GMP).
• Ensure alignment with GMP + internal standards and ALCOA+ data integrity.
• Define Quality expectations for GMP role requirements, qualification/competency evidence, and curriculum assignment rules.
• Provide compliance oversight: trend monitoring, gap analysis, and driving/approving corrective actions when performance drifts.
• Ensure training records are audit-ready (traceable, complete, consistent, inspection-ready).
• Review/approve training materials only for Quality/GMP scope (e.g., Quality training, GMP compliance, SOP/GMP, data integrity).
• Serve as the single Point of Contact (POC) for audits/inspections related to the training system (readiness, presentation, responses, related CAPAs).
• Ensure training impacts are embedded in GMP change controls/projects (impact assessment and closure requirements).
• Support maintenance of the Learning Management System (LMS), including assignment tracking, reporting, and data accuracy.
• Assist with development, revision, and formatting of training materials, curricula, and SOP-related training content
• Partner with subject matter experts to coordinate training logistics and ensure alignment with operational needs
• Performs other duties as assigned by management

Skills

GMP knowledge

Quality systems

LMS familiarity

Training coordination

Microsoft Office

Education

Bachelor’s degree in a scientific, technical, or related discipline

Tools

LMS

Job description

Guerbet, a global leader in medical imaging, seeks a Quality Training Specialist in Raleigh, NC to strengthen GMP training, document control, and regulatory compliance.

You will own the site training system, coordinate cross-functional programs, maintain LMS, and support audits and CAPAs. The role requires a science background and experience in regulated environments. Join a collaborative team dedicated to quality, continuous improvement, and patient safety.