Quality Training Specialist

Guerbet; Raleigh (NC); Sur place; USD 65 000 - 95 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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

Connaissances

GMP training

Regulatory compliance

Training coordination

Formation

Bachelor’s degree in science/engineering

Outils

LMS administration

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

The Quality Training Specialist operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Quality Training Specialist supports the development and execution of training programs that ensure compliance with regulatory requirements and quality standards across site operations. This role partners with cross-functional teams to drive training effectiveness, promote a culture of quality, and support continuous improvement through effective knowledge transfer and performance readiness.

YOUR ROLE

• Act as process owner for the site training system (GMP), including governance, requirements, and continuous improvement.
• Ensure alignment with GMP + internal standards and ALCOA+ principles (data integrity for training records).
• 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

YOUR BACKGROUND

Required 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, learning systems, or compliance-related 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)

Preferred Qualifications

• Advanced degree or certification in Training, Education, Quality, or related field
• Experience in QA, manufacturing operations, or training within a GMP environment
• Prior experience with LMS administration, reporting, or system implementation
• Knowledge of instructional design principles and adult learning methodologies
• Experience supporting audits, inspections, or regulatory interactions
• Familiarity with electronic quality systems (e.g., document management, deviation/CAPA systems)
• Experience with continuous improvement tools (e.g., Lean, Six Sigma)