Supply Chain Sr. Associate

Transportation Qualification Associate

Under general supervision, the Associate supports execution of Transportation Qualification and Cold Chain activities to ensure compliant, risk-based distribution of temperature-sensitive materials. This role partners cross-functionally with Quality, Thermal Engineering (Cold Chain), Manufacturing, and Supply Chain to support qualification studies, documentation, and compliance activities. The focus is execution and documentation

• 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.

• 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 Power Point

• 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.

• 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 Power Point

The typical base pay for this role across the U.S. is: $35.00 - $37.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience.

Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus.

Sick leave and mobile phone reimbursement provided based on state or local law.