SUMMARY OF POSITION Handle the company’s end-to-end all import and export transactions and reports. Responsible for developing, executing material movements strategies that ensure that all imports and exports are handled in accordance with applicable domestic and international customs regulations, trade laws, regulations, and company policies. This role is responsible for maintaining compliance with U.S. Customs and Border Protection (CBP), international customs authorities, and other governmental agencies, while optimizing supply chain efficiency. This role involves collaborating with various departments (internal and external) and clients to identify needs and streamline strategies. Effective communication and strong analytical skills are essential for navigating supply chain Customs trade dynamics and achieving organizational goals. PRIMARY RESPONSABILITIES Ensure import and export activities comply with local, regional, and international regulations (e.g., U.S. CBP, EAR, ITAR, HS codes, customs valuation). Classify products using the Harmonized Tariff Schedule (HTS) and Export Control Classification Numbers (ECCN). Own the Foreign Trade Zone (FTZ) system at site level working directly with the clients and brokers. Prepare and review required documentation for customs clearance including commercial invoices, packing lists, certificates of origin, and shipping documentation, as needed. Coordinate with customs brokers, freight forwarders, and internal stakeholders to facilitate smooth customs clearance and logistics operations. Monitor and maintain import / export records for audits, compliance and internal controls / regulations. Train internal staff on compliance policies and changes in trade regulations. Maintain up-to-date knowledge of trade laws, sanctions, tariffs, and free trade agreements (e.g., USMCA, GSP). Support internal audits and compliance assessments; address discrepancies and implement corrective actions. Partner with cross-functional teams (e.g., procurement, logistics, legal, and sales) to support compliant and efficient trade operations. Interface with government agencies as required (e.g., CBP, BIS, Census, FDA). Conduct internal audits of shipping records, customs entries, and broker activity. Maintain compliance records and documentation in accordance with CBP’s recordkeeping regulation. Support the development and implementation of corrective actions in response to audit findings. Monitor changes in global trade laws, sanctions, and duties; advise internal stakeholders on potential impacts. Comply with all environmental training, procedures, guidelines, practices, cGMP, permit conditions and internal notifications of any environmental event. Perform any other job-related duties as required or that may arise in the future. REQUIREMENTS Education / Experience List the minimum academic credentials and / or years of experience. Bachelor's degree in business relevant discipline; Business, International Trade, Logistics, Supply Chain, Operations Management, or related field; MBA preferred. Three or more (3+) years of experience in the pharmaceuticals business. Three or more (3+) years of experience in managing import / export transactions with U.S. Customs and Border Protection (CBP), international customs authorities, and other governmental agencies. Licenses and / or Certifications Indicate which licenses or professional certifications are required or preferred (Ex. ABC, preferred). Licensed Custom Broker (LCB), preferred or equivalent in experience. Certified Customs Specialist (CCS) or Certified Export Specialist (CES), preferred or equivalent in experience. Technical Competencies Demonstrated Business Acumen. The ability to work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position. Use fact-based analysis; resiliency and understanding of the business needs to articulate how the value of sourcing recommendations and decisions will benefit the business. Regulatory (FDA) industry experience, overall knowledge of manufacturing, packaging in a pharmaceutical environment. Experience working with quality, compliance, plant manufacturing processes, material & production control, and material management. Must have high degree of ethical standards. Maintain a professional demeanor in all situations and be able to withhold confidential information. Attention to details – “Eye-for-detail.” Commitment to being thorough, methodical and systematic. Solid understanding of RFP process and ability to develop and submit RFI and RFP to suppliers. Fully Bilingual, excellent oral and written communication in both English / Spanish languages. Solid understanding of MRP and / ERP systems preferably SAP. Proficient in MS Office Suite applications of MS Project (2010), Outlook, Word, and PowerPoint, and is skilled at performing data evaluation, formulas and metrics in Excel.
Compliance Specialist • BARCELONETA, PR, United States