Location
Groton, CT | United States
Job description
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.
Responsibilities include but are not limited to:
- 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
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
What can Almac Group offer you?
- 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
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 7,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
EEO is the Law
EEO is the Law GINA Supplement
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
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