- Utilize client’s tools and systems (e.g. CSDS, Clementine, GDMS, CAIS, LIMS, SharePoint, etc) to provide transactional support
- Enter/verify information in client’s validated systems
- Document management of both physical and electronical documents in a GMP environment
- Generate reports/documents from multiple systems
- Manage shared mailbox correspondence and action items, as needed
- Creation of protocol specific document folders and compilation of e-documents
- Data entry in non-GMP systems, such as SharePoint
- Partner with client staff in functional areas to perform transactional and project activities within assigned scope of work, activities include but are not limited to:
- Distribution Support (via raising shipments/tracking or assist with tasks such as transfers of material
- Monitoring of stock and usage to support client programs and protocols, as needed
- Create and maintain Drug Plans and API trackers, as needed
- Review and/or approve documentation to ensure quality within a GMP environment
- Providing training support for department, either in a mentoring or system administrator capacity
- Printing of supplies/materials/labels used in operations or expiry updates
- Provide TMF services, where needed
- Performing quality reviews on documentation in validated Trial Master File system, as required
- Track and create metrics of events in client quality management system
- Provide support for audit or inspection requests, as needed
- If needed, perform blinding verification tasks within sample lab on client site
- Provide Operations Supervisor or Project Group Manager with job specific Key Performance Indicators (KPIs), as needed
- Log all billable time against correct program codes and cost centers in time tracking spreadsheet
- Contribute to SOP revisions, efficiency projects or client initiatives, as needed
- High School Diploma/GED and equivalent work experience required
- Bachelor’s with 6+ months customer and/or community service experience or an Associate degree with 2+ years’ work experience or HS / GED with 4+ years’ work experience
- Working in ERP computer systems
- Bachelor's Degree in Science or business-related field preferred
- Knowledge of Pharmaceutical inventory management systems preferred
- Pharmaceutical or clinical supplies industry experience
- Project management experience within a manufacturing environment preferred
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Professional development programs/ continuous learning opportunities