Production Packaging Coordinator

Job Post Index 22F8EE-Sy##
Location Groton, CT
Description: Description
  • 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
Skills: Qualifications
  • 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
  • Familiarity with clinical trials, clinical trial packaging, and/or supply chain preferred
  • At least 2 years of corporate experience 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

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