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.
Completes tasks associated with clinical supply packaging with pre-identified external partners.
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.
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.
Follow written SOPs and business practices and will raise any deviations to the EVPC for triage and escalation.
Create and approve packaging requests within a GMP system
Review and approve vendor packaging and labeling 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 in local scheduling system
Escalate issues as appropriate for immediate resolution
Reviewing documentation to compare to aligned with SOPs to approve if sufficient or reject and escalate for additional action
Manage milestones assigned within project, accurately track progress, meet deadlines and escalate items to the Packaging Coordination for resolution
Bachelor's degree in a scientific or technical discipline (chemistry, biology, pharmacy, engineering, etc) preferred
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
Ability to collaborate
Project management skills
Knowledge of Good Manufacturing Practices (GMP) preferred