Quality Training Specialist M/F (30691)

Laboratoire Guerbet•Raleigh, IL

About The Position

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.

Requirements

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)

Nice To Haves

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)

Responsibilities

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