Quality Import Export Specialist

Uniphar Group; North Carolina; On-site; USD 28,000 - 40,000; Full time

Job summary

Uniphar is seeking a Quality Import/Export Specialist in New Jersey to oversee day-to-day quality for commercial import/export activities, ensuring adherence to GDP, GDP/GDocP, and applicable regulations. The role reports to the US Head of Quality and coordinates with operations and logistics partners to maintain quality across distribution processes.

Key responsibilities include ensuring proper documentation, release approvals, and risk mitigation for shipments, with ongoing collaboration

Responsibilities

• Quality oversight for commercial import/export activities to ensure regulatory and procedural compliance.
• Collaborate with Operations, Supply Chain, and Brokers to resolve shipment quality issues.

Job description

Location: Garner, New Jersey

Pay: $25.00 per hour

About Uniphar:

Uniphar, founded in 1967, is a leading, global, full-service life sciences and healthcare services company that has grown and expanded its operations internationally across Europe, the USA, MENA and APAC. Working from clinical development to commercialization, our end-to-end services remove barriers to launch, increase access and optimize brands. Capabilities span across consulting, communications, global supply chain, regulatory compliance, medical affairs, medical communications, medical information, field (msl, sales, virtual), access, agency, research, digital, and in-licensing. We have over 3.5K employees, $3 billion in annual revenue, over 200+ multinational partners, and deliver medications to more than 180 countries. Uniphar US operations include integrated services from Uniphar Clinical, Uniphar Logistics, Uniphar Medical, and Uniphar Commercial including Access and Supply chain. We deliver exceptional results driven by trust, innovation, and our patient-first culture. Check out our EVP and why you should work for us: https://uniphar.euwest01.umbraco.io/media/44rfphln/uniphar-pharma_evp_2024_pdf_v2.pdf. US Uniphar Website: www.uniphar.us.

Why Join Us?

• Competitive salary: $25 per hour
• Comprehensive benefits: health, dental, vision, 401(k) match, and more
• A collaborative, flexible work environment that supports career growth
• Opportunity to make a global impact in the dynamic life sciences industry

Role 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 Quality 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 escape potential 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:

• 1. 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 invoices
  • Packing lists
  • Shipping documentation
  • Product descriptions
  • Lot/batch information
  • Quantities
  • Country of origin
  • Country of destination
  • Customer/consignee information
  • Required permits, authorizations, notifications, or licenses
  • Temperature-control requirements
  • Certificates of Analysis
  • Certificates of Conformance
  Coordinate 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 escape 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.
• 2. Distribution Quality and Shipment Compliance OversightReview shipment records to verify compliance with approved