What We’re Looking For
The Import/ Export Specialist will perform daily tasks under supervision and be responsible for coordinating and managing international shipments to ensure timely, compliant, and cost-effective importation and exportation of goods. In addition, this role will adhere to procedures to ensure compliance with state and federal regulatory agencies.
What You Will Do
• Prepare, review and submit documentation for import and export of goods.
• Facilitate regulatory clearance of import and export goods
• Track and monitor entries daily to manage clearance
• Proactively address import delays, holds, or compliance concerns
• Maintain PCCA’s relationship with its broker
• Review and approve broker invoices for accuracy including duties, storage charges and additional fees
• Maintain compliance with SOPs in a Good Manufacturing Practice (GMP) environment
• Assist in monitoring compliance plans based on state and federal regulations
• Assist in tasks required to maintain PCCA licensing with appropriate state boards and regulatory agencies
• Create and maintain work instructions supporting Regulatory Affairs processes
• Input customer orders, update customer DEA licenses, release sales orders for shipping and maintain suspicious order monitoring
• Verify inventory for controlled substances and List chemicals for all sites
• Conduct inventory reconciliation and intradepartmental audits
• Review Controlled Substance work orders and inventory records
• Assist in updating and maintaining Regulatory Affairs Standard Operating Procedures (SOPs)
• Assist with documentation of deviations and change controls
• Assist with responding to interdepartmental and external regulatory agency requests
• Generate and review regulatory documentation required for customers, manufacturers and/or products.
• Complete regulatory affairs responsibilities for item set-up, Average Wholesale Price (AWP) and National Drug Code (NDC) product data
• Complete FDA product and establishment submissions
• Update and maintain Regulatory Affairs SharePoint site and document repositories.
• Facilitate interdepartmental communication and provide information for team members in other departments related to regulatory affairs
• Complete Regulatory Affairs state reporting
• Assist with related special and interdepartmental projects, as assigned
Who You Are
• Must be detail oriented and able to work independently as well as in a team environment
• Prior experience with international cargo transportation and pharmaceutical insurance practice required
• Three years of experience in a GMP environment required
• Three years of experience in DEA and FDA regulations required
• Prior exposure to ERP and basic knowledge of supply chain flow
• Ability to use and navigate Microsoft Word, Excel, Outlook, Adobe, and SharePoint
• Must have customer service skills including one year of order entry or Customer Service experience
• Intermediate organizational, interpersonal, multi-tasking, presentation, verbal and written communication, and time management skills
• Bachelor’s Degree, a plus
Who We Are
PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patients’ lives. As a complete resource for independent compounding pharmacists, PCCA provides high-quality products, education, and support to more than 3,000 pharmacy members throughout the United States, Canada, Australia, and other countries around the world. Incorporated in 1981 by a network of pharmacists, PCCA has supported pharmacy compounding for more than 40 years. Learn more at www.pccarx.com.
Qualifications Skills Required Emailing Intermediate Time Management Intermediate Communication Intermediate Word, PowerPoint, Excel Intermediate Conflict Management Intermediate Collaborating Intermediate Active Listening Intermediate Critical Thinking Intermediate Behaviors Required Innovative: Consistently introduces new ideas and demonstrates original thinking Team Player: Works well as a member of a group Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well Equal Opportunity Employer
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What We Do
PCCA is a complete resource for compounding pharmacies. Our members are nearly 4,000 community pharmacists in the United States, Canada, Australia and other countries around the world. We were incorporated in 1981 by a network of pharmacists who recognized the need to help patients requiring customized medications.
