Minimum 5 years’ experience in Quality in an FDA regulated industry
Minimum of 3 years Distribution center/logistics experience, inclusive of processes & electronic systems for distribution and inventory management
Responsibilities
Support the development, implementation and maintenance of efficient, effective and compliant quality systems at the distribution level supporting product record reviews/system release
Release of product for distribution across business units, Non-conformance/CAPA management, Change Management, Document Management, Records Management, Data Integrity, Risk Management and Training
Additional support/oversight regarding product/process investigations, Supplier Management, internal/corporate/external audit support, process/continuous improvement, compilation of site quality/compliance metrics, including Management Reviews
Provide Quality support to Inventory Control, when necessary as well as evaluate/approve damaged, aged or expired product for destruction, both internally and with third party logistics centers
Develop, implement, and maintain global logistics standards across Supply Chain Quality (storage & transportation, to include global guidance on managing shipping lanes and temperature excursions during transport, etc.)
Develop, implement, and maintain supplier management in company systems (Catsweb) for these type suppliers
Arrange & conduct 3PLs, distributor and transportation supplier qualifications
Create, update, and maintain Quality agreements
Manage Supplier Audit Program for 3PLs, datalogger, and transport providers
Ensure Good Distribution Practices (GDP), temperature controls, results, and traceability requirements are established and monitored
Provide supplier performance results & escalate issue to management, when appropriate
Propose solutions with action plans to resolve, when appropriate
Manage and/or participate in projects to continuously improve logistics (storage and transport)