THE GLOBAL, AWARD WINNING, "PEOPLE" PEOPLE
A SERVICE DISABLED VETERAN OWNED BUSINESS
About the Role
Key Responsibilities
• Support execution of transportation qualification studies, including coordination with Thermal Engineering Labs and Sample Management.
• Collect, organize, and analyze temperature monitoring and shipment data.
• Drafting qualification protocols and reports; perform data gathering, analysis, and interpretation.
• Support deviation investigations, change controls, and CAPA documentation related to transport activities.
• Drafting documentation to support Marketing Authorization Applications (MAA) and respond to regulatory agency inquiries related to transportation.
• Maintain transportation SOPs and controlled documents in compliance with GMP/GDP requirements.
• Collaborate with Quality and Thermal Engineering to interpret data and ensure inspection-ready documentation.
• Track qualification timelines and support cross-functional project coordination.
• Perform basic shipment performance trending and support risk assessments.
• Manage and support multiple transportation studies simultaneously, often at different lifecycle phases.
• Contribute to and drive continuous improvement projects in cross-functional collaboration.
Requirements
Basic Qualifications
• Bachelor’s degree in science, Engineering, Supply Chain, or related field
• 0–3 years of experience in pharmaceutical, biotech, manufacturing, or regulated industry
• Understanding of GMP principles (academic or professional exposure)
• Strong documentation and organizational skills
• Strong analytical skills with the ability to turn complex information into clear, practical insights.
• Proficiency in Microsoft Excel, Word, and PowerPoint
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Preferred Qualifications
• Exposure to cold chain, validation, or quality systems
• Familiarity with deviation, CAPA, and change control processes
• Experience working in cross-functional teams
• Familiarity with parcel, transport, and warehousing provider operations.
• Ability to independently interact with various levels, drives tasks to completion.
• Strong negotiation and problem-solving skills.
Job Application
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