JOB SUMMARY
The Documentation, Learning & Quality Systems Analyst is primarily responsible for the administration and optimization of the Learning Management System (LMS) and Document Management System (DMS), while supporting the broader Quality Management System (QMS). This role contributes to maintaining GxP-compliant processes, ensuring training and documentation compliance, and supporting quality initiatives, self-inspections, audits and continuous improvement activities across the organization.
DUTIES AND RESPONSIBILITIES
Learning Management System (LMS) & Training Management Support
- Manages training matrices and assigns training curricula in alignment with role-based requirements.
- Administers training assignments, notifications, and escalations within the LMS.
- Performs timely follow-ups with stakeholders to ensure training completion and compliance.
- Monitors, analyzes, and reports training compliance metrics and KPIs.
- Identifies trends, gaps, and opportunities for continuous improvement in training effectiveness.
- Supports periodic review and optimization of training programs to ensure GxP compliance.
Document Management System (DMS) Support
- Supports the lifecycle management of controlled documents including creation, review, approval, issuance, revision, and archival.
- Tracks and analyzes compliance with document review and approval workflows.
- Performs document change control impact assessments in collaboration with the Quality team.
- Maintains document repository integrity and ensures adherence to document control standards.
Quality Management System (QMS) Support
- Supports QMS processes including change controls, QEs, CAPAs, training compliance, and document control.
- Assists in monitoring QMS metrics and identifying meaningful trends for continuous improvement.
- Supports the development, review, & maintenance of quality procedures (SOPs, POLs, WIs).
- Proactively contributes to quality improvement initiatives and cross-functional process enhancements.
General Quality Compliance Responsibilities
- Maintains professional records (Job Descriptions, CVs, Organizational Charts) in compliance with GxP requirements.
- Monitors and manages the LMS mailbox, addressing and escalating requests, as needed.
- Supports audit readiness activities related to LMS, DMS, and QMS processes.
- Supports administration and continuous improvement of LMS, DMS, and related QMS tools.
- Performs other duties as assigned.
