Quality Import Export Specialist
UnipharQuality Import / Export SpecialistLocation: Garner, New JerseyPay: $25.00 per hourRole Overview:The Quality Import / Export Specialist is responsible for providing day-to-day Quality oversight and compliance support for commercial pharmaceutical import and export activities, ensuring compliance with approved procedures, customer requirements, applicable regulatory requirements, and the company's Q
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uality Management System (QMS).Reporting directly to the US Head of Quality, the Quality Import / Export Specialist serves as the primary Quality representative for commercial import and export operations and ensures that importation, exportation, shipment review, product release, documentation review, transportation activities, and related distribution processes are performed in accordance with approved Standard Operating Procedures (SOPs), Good Distribution Practices (GDP), Good Documentation Practices (GDP/GDocP), applicable federal and state regulations, customer requirements, and the company's QMS.The Quality Import / Export Specialist is expected to maintain active oversight of commercial import and export activities, identify and escalate compliance risks, provide Quality guidance regarding shipment requirements and documentation reviews, and work collaboratively with Operations, Supply Chain, Customer Service, Regulatory Affairs, freight forwarders, and customs brokers to ensure Quality and compliance requirements are integrated into daily operations while maintaining Quality independence.Essential Duties and Responsibilities:The primary responsibilities include, but are not limited to the following:Commercial Import and Export Quality OversightServe as the Quality representative for commercial import and export activities within the assigned US operation.Provide Quality review and oversight of commercial import and export transactions to ensure applicable regulatory, licensing, customer, product, and procedural requirements are satisfied.Review import and export documentation for completeness and accuracy, as applicable, including:Commercial invoicesPacking listsShipping documentationProduct descriptionsLot/batch informationQuantitiesCountry of originCountry of destinationCustomer/consignee informationRequired permits, authorizations, notifications, or licensesTemperature-control requirementsCertificates of AnalysisCertificates of ConformanceCoordinate with Operations, Supply Chain, Customer Service, brokers, freight forwarders, and other stakeholders to resolve Quality-related shipment issues.Verify that applicable products, customers, destinations, and shipment activities are permitted under company procedures and applicable regulatory requirements.Ensure required Quality approvals are obtained before commercial product is released for importation or export.Identify and escalate potential compliance concerns that could result in customs delays, product detention, product refusal, regulatory violations, or customer impact.Support investigations associated with shipment discrepancies, customs hold, documentation errors, damaged shipments, temperature excursions, rejected products, and other distribution events.Ensure applicable records supporting commercial import and export activities are maintained in accordance with established retention requirements.Support development and maintenance of procedures governing commercial import/export Quality activities.Distribution Quality and Shipment Compliance OversightReview shipment records to verify compliance with approved procedures and customer requirements.Review temperature-monitoring records associated with temperature-controlled shipments.Support Quality assessment of transportation deviations and temperature excursions.Monitor compliance associated with:International shipmentsDomestic distribution of imported productsProduct receipt and distribution activitiesTemperature-controlled transportationShipment releaseDocumentation and record retentionProduct traceabilityEnsure