Import/Export Specialist

PCCA USA, PCCA Canada•Houston, TX

About The Position

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.

Requirements

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

Nice To Haves

Bachelor’s Degree, a plus

Responsibilities

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