Position performs activities related to Global Logistics and inventory management to support customer and manufacturing sites in cooperation with internal and external partners. The role requires an understanding of GXP, planning / scheduling, inventory management, clinical and commercial logistics, cold chain, import / export, and global trade compliance. The individual will be responsible for logistics for international bulk material movements, all phases of clinical studies, expanded access / named patient programs and commercial supply for the company. The candidate has a demonstrated ability to work independently and expediently to obtain tangible results.
KEY RESPONSIBILITIES
Create / Support shipments for bulk drug substance, drug product, finished goods, intermediates and sample shipments to global sites.
Manage and execute shipping forecast with Clinical / Commercial Operations.
Create shipment documents, e.g. Commercial Invoices for import or export, End Use Letters, USDA Letters, import applications and permits.
Create Distribution Protocols for third party Contract Manufacturing Organizations (CMOs) and 3PL Distribution Centers.
Create SOPs / COPs for company approved freight carriers.
Maintain shipment database to record and track all shipments and record keeping of shipment documentation, communications, and temperature results.
Manage Deviations due to temperature excursions or shipment discrepancies in Veeva QMS.
Execute appropriate inventory movement transactions within the company ERP system.
Perform inventory reporting and reconciliation monthly, or as required.
Provide internal customer service for shipment requestors across all offices and programs.
Create and maintain relationships with company approved carriers, 3PLs, and CMOs.
Assist Finance with inventory reconciliation and financial close.
Track all shipment issues (damage, temperature excursions, non-compliance, etc.) and work to resolve recurring problems with permanent solutions.
Enforce consistency and compliance with the company Global Logistics policies, procedures and applicable regulatory authority directives and regulations.
Follow the company procedures and requirements associated with Global Trade Compliance.
QUALIFICATIONS
Bachelor's Degree required.
3-5 years in a Supply chain or Pharma / Biotech Cold Chain Logistics environment.
Working knowledge of GMP, GDP, pharmaceutical industry procedures and regulations.
Familiarity with SOPs, SOW, COPs and Distribution Protocols
Experience with Quality Management systems (Veeva experience a plus).
Flexibility and the ability to manage change.
Excellent written and verbal communication skills.
Well-developed interpersonal skills and the ability to work well as part of a team.
Solid organizational, time management and project management skills.
Strong interest in Supply Chain and Logistics.
Numbers & Facts
Location
Austin, TX (Remote)
Industry
Staffing/Employment Agencies
Salary
$80 Per Hour
Company Size
20 to 49 employees
Year Founded
2008
Website
http://www.platinumresourcegroup.com
About Company
Platinum Resource Group is a professional level consulting firm, providing resources to Fortune 1000 client companies in the areas of technology, human resources, accounting, finance, business systems and supply chain, on a contract and interim basis. PRG has operations in Orange County, San Diego, Los Angeles and San Francisco. As a W-2 employer we offer our consultants direct deposit bi-weekly payroll, health, dental, vision benefits, paid holidays, and referral bonuses.
Skills
Accounting Closeunmatched
Billingunmatched
Biotech and Pharmaceuticalunmatched
CMOSunmatched
Calendar Managementunmatched
Cargo/Freightunmatched
Change Controlunmatched
Change Managementunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Contract Manufacturingunmatched
Corporate Complianceunmatched
Corporate Policiesunmatched
Customer Support/Serviceunmatched
Database Administrationunmatched
Distribution Servicesunmatched
Document Controlunmatched
Drug Productsunmatched
ERP (Enterprise Resource Planning)unmatched
Forecastingunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Import/Exportunmatched
Interpersonal Skillsunmatched
Inventory Managementunmatched
Inventory Reportsunmatched
Inventory Transactionsunmatched
Logisticsunmatched
Logistics Managementunmatched
Manufacturingunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Project/Program Managementunmatched
Quality Managementunmatched
Reconciliationunmatched
Record Keepingunmatched
Regulationsunmatched
Shipping Documentsunmatched
Standard Operating Procedures (SOP)unmatched
Statement of Work (SOW)unmatched
Supply Chainunmatched
Team Playerunmatched
Third-Party Logistics (3PL)unmatched
Time Managementunmatched
United States Department of Agriculture (USDA)unmatched
Writing Skillsunmatched
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