Project Coordinator - Extended Outsourcing
Almac Group
Summary
Almac Group is currently seeking a Project Coordinator – Extended Outsourcing for our Groton, CT location. The Project Coordinator – Extended Outsourcing supports client global clinical supply as it relates to transactional and project activities within assigned scope of work. Fully Onsite in the Groton, CT Location.
Job description
Responsibilities
- 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
- 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
Qualifications
Required Experience / Education:
- 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
Preferred Experience / Education:
- 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
Requirements
- 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
Benefits
- Medical, Vision & Dental benefits
- 20 days PTO per year
- 12 holidays per year
- Company paid Long and Short-term disability
- Life Insurance
- 401k company contribution
- Professional development programs
- Continuous learning opportunities
Company overview
Almac Group is a global contract development and manufacturing organization (CDMO) that provides comprehensive integrated services across the entire drug development lifecycle. Founded over 55 years ago, the company has grown into a major player in the pharmaceutical and biotechnology sectors with operations spanning the UK, Ireland, United States, and Asia. Almac offers a complete range of services including R&D, biomarker discovery, API manufacturing, formulation development, clinical trial supply management, and commercial-scale manufacturing. The organization employs over 7,800 professionals globally and has contributed to approximately 50% of FDA-approved new molecular entities in recent years. With 18 facilities worldwide, Almac serves all top 25 biopharmaceutical companies and supports client portfolios in over 65 countries. The company operates through specialized divisions including Almac Sciences for API services, Almac Pharma Services for drug product development, Almac Clinical Services for clinical supply chain management, and Almac Diagnostic Services for precision medicine solutions. Almac's commitment to excellence and long-term client partnerships has established it as a trusted partner in advancing human health through innovative pharmaceutical development and manufacturing solutions.