GMP Training & Compliance Specialist

Guerbet; Raleigh (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Guerbet seeks a Quality Training Specialist to own the GMP training program, ensuring data integrity and audit readiness across site operations. You will partner with cross-functional teams to develop, revise, and deliver compliant training materials and curricula, while maintaining the Learning Management System and documenting alignment with COA/ALCOA+ standards.

Ideal candidates bring 2–5+ years in regulated environments, proficiency with LMS and MS Office, and a proven ability to manage

Qualifications

• Bachelor’s degree in a scientific, technical field or equivalent experience.
• 2–5+ years in a regulated environment (pharma, biotech, medical device).
• Knowledge of cGMP regulations and quality systems requirements.
• Experience with LMS and training documentation practices.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

Responsibilities

• Act as process owner for the site training system (GMP).
• Ensure alignment with GMP standards and ALCOA+ data integrity for training records.
• Define quality expectations for GMP role requirements and curriculum rules.
• Provide compliance oversight: trend monitoring, gap analysis, and CAPA closure when performance drifts.
• Ensure training records are audit-ready and traceable.
• Review/approve training materials for Quality/GMP scope.
• Serve as the single Point of Contact for audits/inspections related to the training system.
• Ensure training impacts are embedded in GMP change controls and projects.
• Support LMS maintenance: assignment tracking, reporting, and data accuracy.
• Assist with development and formatting of training content; coordinate training logistics with SMEs.
• Perform other duties as assigned by management

Skills

GMP training

Regulatory compliance

Training coordination

Education

Bachelor’s degree in science/engineering

Tools

LMS administration

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Guerbet seeks a Quality Training Specialist to own the GMP training program, ensuring data integrity and audit readiness across site operations. You will partner with cross-functional teams to develop, revise, and deliver compliant training materials and curricula, while maintaining the Learning Management System and documenting alignment with COA/ALCOA+ standards.

Ideal candidates bring 2–5+ years in regulated environments, proficiency with LMS and MS Office, and a proven ability to manage