The Internal Logistics Coordinator will coordinate internal clinical and commercial logistics across the cGMP warehouse to ensure compliant, timely movement and availability of materials from Drug Substance through Labeled Drug Product (active and placebo). Partner closely with internal colleagues to maintain inventory accuracy, temperature control integrity, and end-to-end traceability.
Responsibilities:
- Orchestrate daily material flows within the warehouse (receiving, quarantine, sampling, release, staging, pick/pack, kitting, and shipping) to support production schedules and clinical dispatch plans.
- Serve as the initial point of contact for internal drug supply transportation and material movement requests; prioritize, schedule, and confirm transfers between areas and sites.
- Maintain lot-level, batch-level, and expiry traceability using WMS/ERP; enforce FEFO/FIFO, status segregation (quarantine/released/rejected), and correct labeling.
- Prepare compliant pack-outs for CRT, refrigerated, and frozen materials; verify shippers, conditioning, coolant loads, packing configuration, and documentation.
- Coordinate cycle counts and inventory reconciliations; investigate variances, implement corrective actions, and update master data as needed.
- Execute temperature monitoring activities: device allocation, calibration status checks, programming, deployment, data download, and reconciliation.
- Triage and document temperature excursions; initiate EOEs/NOEs and deviation records, support impact assessments, and drive closure with QA.
- Create and maintain shipping documents and compliance records per GDP/cGMP and ALCOA+ principles; ensure timely collection, scanning, and long-term archiving.
- Support and track change controls, NOEs, EOEs, SCARs, and DNFs; partner with QA on investigations and effectiveness checks.
- Keep accurate databases and dashboards; generate inventory position reports and schedules to assess Drug Supply availability and risk.
Qualifications:
- Associates degree required.
- Logistics Coordinator II: 4+ years of relevant experience.
- Logistics Coordinator III: 6+ years of relevant experience.
- May consider experience in lieu of education.
- Bachelorβs degree and experience in a GMP regulated environment preferred.
Skills/Requirements (May Be For You If):
- Working knowledge of Microsoft Applications, including Excel, Teams, and Sharepoint.
- Working knowledge of quality systems/software (e.g., QUMAS or similar).
- Working knowledge of word processing, spreadsheet, database management, graphing, and presentation software.
- Problem-solving skills and ability to provide creative solutions to complex problems.
- Experience with Oracle ERP system preferred.
- Strong interpersonal skills; build relationships across internal/external stakeholders.
- Ability to multi-task and shift priorities routinely; contribute to a team and facilitate meetings at times.
Application instructions:
- Apply now.
Salary Range (hourly): $24.76 - $44.42