Document & Training Specialist, Radioconjugate PQS
Core
Administer controlled document management and learning management systems to ensure SOPs, training curricula, and records comply with GxP regulations and data integrity principles.
Role type
Entry-level Quality Systems Specialist (Document & Training)
Builds
Regulated document archives and compliant training records for a clinical-stage oncology company
Domain
Life Sciences / Pharmaceutical Quality Systems
Deliverable
dashboards & analysis
Required skills
Document lifecycle management, LMS administration, GxP compliance, Change control interface, Audit support, Data integrity (ALCOA+), Regulatory record retention
Preferred skills
Veeva Vault (eDMS/eQMS), UL ComplianceWire (eLMS), Power BI, Manufacturing workflows
Technologies
Veeva Vault, UL ComplianceWire, SuccessFactors, Cornerstone, Microsoft 365
Responsibilities
Process document revisions and retirements in eDMS, Review documents for formatting and GDP adherence, Link document changes to change controls and CAPAs, Maintain document archives per retention schedules, Create and assign training curricula in LMS, Monitor training completion and generate compliance reports, Support internal and health authority audits, Compile metrics on document cycle times and training compliance
Seniority
Entry-level, hands-on IC