- Coordinate document workflow and training module administration in LEADs across multiple departments assisting line managers directly.
- Support Quality File Rooms (QFR s), on and off-site archiving/records management
- Support Principal Archivist (PA) program, disaster recovery, vital records, and departmental internal audits to ensure compliance with relevant procedures
- Maintain inspection readiness for documentation, training and archiving. activities for Oncology & Biologics Quality and Operations, TBOS Facilities and TBOS GMA.
- Perform document submissions, scanning, retrievals and off-site archiving ensuring accuracy with archive indices
- Support PA Program and projects where applicable
- Process assigned document types for workflow initiation, to include expiration review compliance
- Act as customer support liaison to documentation and file room customers
- Act as primary contact and support to assigned departments for LEADs workflows and training management. Fields questions and issues from functional staff.
- Create and manages training modules in LEADs (sets prerequisites, initial & re-training periods, substitutes);
- Coordinate training assignment for employees in assigned areas
- Provide reports and support as needed for quality audit / inspection activities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- High school diploma with 1-3 years experience in pharmaceuticals within GxP environment or Bachelors degree in related subject
- Prior experience with documentation, archiving/record management systems/processes preferred
- Strong communication skills
- Collaborative skills and a strong customer service mindset
- Proactive, self-directed working style
- Ability to multi-task and assist in the support of small projects
- Prior experience using validated documentation and training management systems preferred