• Responsible for E2E operations conducted in PQC Sample Room
• On site support 5 days/week, ability to work wearing PPE
• Responsible for handling used complaint samples
• Process returned complaint samples as per PQC Sample Room Manual
• Identifies and handles lot discrepancies correctly with returned complaint samples.
• Updates the complaint records in the systems.
• Prepares products for shipments to the manufacturing sites
• Prepare shipping labels using FedEx equipment.
• Assemble shipping containers to the sites
• Responsible for resolving all discrepancies directly with the reporters
• Create new complaints in both Meteor and Qualipso
• Identify complaints for FAR/BPDR (Field Alert and Biological Product Deviation Report) reporting as necessary
• Use various Excel reports for daily operations.
• Act as a SME on PQC Sample Room operations and provide support during audits and inspections
• Act as a trainer for new associates
• Manage PQC Sample Room Manual
• Complete all required trainings (i.e. DOT, IATA, blood borne pathogens)
• Manage all supplies and maintain inventory required for daily operation of a PQC Sample Room
• Order supplies and work directly with the vendors for customized PO
• Responsible for maintaining all equipment and tools in PQC Sample Room
• Proficient with use of all databases within the department (ie. Meteor, Qualipso, Microsoft Office).
• Understands the importance of processing GxP data according to GDP foundations
• Understands PQC process flow
• Understands the FDA complaints regulations for the drug, combinations products and medical devices.
• Maintains PQC reports as needed
• Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
• Prepare international shipping manifests, commercial invoices and customs forms
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial, Operations, Legal, and Risk Management.
• Performs other duties as assigned.
• Ability to lift/move 20lb and work standing 50%
• Maintains use of Universal Precautions while working
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