This role is responsible for ensuring warehouse and materials management operations support. This is a hands-on role responsible for daily on-the-floor activities in support of GMP systems for a clinical-stage cell therapy company.
Responsibilities:
Receive incoming shipments of non-GMP/GMP materials and equipment following established procedures.
Coordinate and perform disposition of all expired materials and maintain applicable documentation.
Dispense GMP materials and assemble Kits to support production operations.
Maintain accurate inventory of GMP warehouse materials (Inventory Management)
Perform inventory cycle counts and communicate any inventory discrepancies to Materials Manager.
Perform accurate ERP transactions.
Collaborate with Manufacturing, Quality Control, and Quality Assurance in supporting internal and external materials management operations, and resolution of issues.
Coordinate warehouse operations in the cGMP facility including receiving, storage of raw materials in properly designated locations (e.g., raw materials, freezers (-20, -80C and LN2) and refrigerated locations), picking and component preparation (Kitting) for manufacturing, and product shipping.
Other duties as assigned.
Job Qualifications and Skills
1-3 years of materials management or supply chain experience at an FDA-regulated pharmaceutical, biotech or medical device company, or GMP facility
Knowledge and understanding of GxP and relevant ICH and FDA guidelines
Experience in cold chain management in a biopharmaceutical or medical device setting
Experience with Insight68 or other Inventory Management System
Willing to accept temporary responsibilities outside of initial job description
