- Title: Production Packaging Coordinator
- Code: RCI-17477-1
- Location: Groton Connecticut (CT) 06340
- Posted Date: 01/14/2020
- Duration: 12 Months
Clinical Supply Packaging (CSP) is part of the Medicinal Sciences Global Clinical Supply (GCS) Group. Our purpose is to provide packaging solutions based upon a commitment to reliability, trust, confidence and ease of customer interaction to deliver quality packaged clinical supplies to the patient.
The Production Packaging Coordinator (PPC) completes tasks associated with clinical supply packaging with pre-identified external partners. These tasks include setting up the details of the packaging job; authoring and approving documents; verifying and approving pre- and post-packaging batch records; performing actions in GMP systems; and recording completion milestones in the scheduling system. The PPC will primarily interact with the External Vendor Packaging Coordinator (EVPC), who acts as the project manager for program-level packaging strategy, and the external vendors where the packaging is being conducted. The PPC will follow written SOPs and business practices and will raise any deviations to the EVPC for triage and escalation.
- Create and approve packaging requests within the Clinicopia system
- Review and approve vendor packaging and labelling documentation (batch records)
- Create and maintain documents within the Global Document Management System
- Perform verification checks for External Vendor Packaging Coordinators
- Manage milestones associated to the project plan for each packaging job
- Escalate issues as appropriate for immediate resolution
- Meticulous attention to detail; quality orientation
- Fluency with basic Microsoft applications (Word, Excel, Outlook)
- Ability to learn new systems quickly
- Excellent verbal and written communication skills and ability to collaborate
- Project management skills
- Knowledge of Good Manufacturing Practices (GMP) preferred
- Familiarity with clinical trials, clinical trial packaging, and/or supply chain preferred
- Mandatory attention to detail, organized, meticulous!
- Documentation management required!
- GMP knowledge strongly preferred
- GDMS experience strongly preferred
- Familiarity with Clinical Trials, Supply Chain, Packaging, etc. highly preferred!
- Bachelor's degree in a scientific or technical discipline (chemistry, biology, pharmacy, engineering, etc)
- At least 2 years corporate experience desired (including internships >5 months)