GMP Training & Compliance Specialist

Guerbet; Raleigh (NC); Vor Ort; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Guerbet is seeking a Quality Training Specialist in the United States (Raleigh, NC) to develop and manage GMP training programs across site operations. The role ensures regulatory compliance, data integrity, and effective knowledge transfer through the Learning Management System (LMS).

Collaboration with cross‑functional teams will drive training effectiveness and continuous improvement. The ideal candidate has a scientific/technical degree with 2–5+ years in regulated environments, strong

Qualifikationen

• Bachelor’s degree in a scientific, technical, or related discipline.
• 2–5+ years of experience in a regulated environment (pharma, 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 (Word, Excel, PowerPoint).
• Advanced degree or certification in Training, Education, Quality, or related field (preferred).
• Experience in QA, manufacturing operations, or training within a GMP environment (preferred).
• Prior experience with LMS administration, reporting, or system implementation (preferred).
• Knowledge of instructional design principles and adult learning methodologies (preferred).
• Experience supporting audits, inspections, or regulatory interactions (preferred).
• Familiarity with electronic quality systems (e.g., document management, deviation/CAPA systems) (preferred).
• Experience with continuous improvement tools (e.g., Lean, Six Sigma) (preferred).

Aufgaben

• 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

Kenntnisse

GMP knowledge

LMS familiarity

Documentation practice

Organizational skills

Communication skills

Problem solving

Microsoft Office

Ausbildung

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

Tools

LMS

Jobbeschreibung

Guerbet is seeking a Quality Training Specialist in the United States (Raleigh, NC) to develop and manage GMP training programs across site operations. The role ensures regulatory compliance, data integrity, and effective knowledge transfer through the Learning Management System (LMS).

Collaboration with cross‑functional teams will drive training effectiveness and continuous improvement. The ideal candidate has a scientific/technical degree with 2–5+ years in regulated environments, strong