Tracy Killingsworth

Experience

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  Alcon Laboratories, Inc.

  Aug 2006 - Jul 2014

  Manage risk and improve internal processes for import and export trade compliance. Perform focused assessments, manage cross-functional projects, analyze and document compliant utilization of Free Trade Agreements such as NAFTA/Duty Draw Back/US goods returned. Subject matter expert for CBP OGA (other government agencies) such as FDA, USDA, FCC, CDC, DOT, US Fish & Wildlife, etc.). Broker management. Review and approve transactions requiring OFAC and/or BIS licenses for export. Research and supply information to Alcon’s broker required for imports of commercial & non-commercial shipments. Expert in OGA (other government agencies) Trade Compliance, HTSUS, HTS, ECCN classification. Certified quality auditor (ASQ CQA), perform quality audits of chemical suppliers, internal audits, cGMP audits according to ICH Q7, IPEC GMP, 21 CFR Parts 210, 211, 820, and 11, as well as ISO 13485. Compendial compliance liaison for USP/EP/JP. Evaluate existing and new research equipment to determine validation and user requirements for both hardware and software. Develop, write, execute, and review validations for systems. Manage validation life cycle from purchase to retirement. Expert in computer system validations and FDA 21 CFR Part 11 compliance.

  • Manager-Global Trade Compliance

    Oct 2012 - Jul 2014

  • Sr. Logistics Analyst-Global Trade Compliance

    Dec 2011 - Oct 2012

  • SR Auditor II

    Aug 2008 - Dec 2011

  • SR. Validation Scientist

    Aug 2006 - Aug 2008
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  Ken Block Consulting

  Oct 2014 - Mar 2015

  Trade Compliance Manager

  Prepare Japanese companies for initial FDA inspection of: software/system validation, electronic records, electronic signatures, trade compliance, and partner quality agreements. Provide expert level knowledge to client staff regarding FDA validation requirements and trade compliance. Develop and conduct classroom training in FDA “Part 11” compliance requirements.

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  Army & Air Force Exchange Service (AAFES)

  Apr 2015 - now

  Import Compliance Analyst II (S)

  • Perform all pre-entry activities including HTS classification, OGA, FTA, COO, MID, etc. Prepare and transmit complete broker packets of all shipments via Amber Road software to AAFES broker. Implement and validate trade compliance software. Manage RPS lists.• Develop/monitor tools to support compliance activities: duty reduction using first sale program, duty drawback, tariff engineering, and free trade agreements. Conduct compliance reviews for company declarations. Implement improvements to minimize potential risks. Monitor Section 301 tariff impacts and identify duty savings opportunities.• Collaborate with supply chain (buyers, agents, vendors, QA) to improve product sourcing and reduce shipping costs via route selection/MOQ. Improve processes and systems related to compliance metrics.• Import Transportation Management and accounting, optimization of ocean freight, KPIs on spending, container utilization, supervise Import Trans Tech. • Security clearance: Secret Show less