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
Top 3 Must Have Skill Sets:
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
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.
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
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.
Key Attributes:
Detail-oriented and compliance-focused
Analytical and comfortable working with data
Flexible and able to manage shifting priorities
Strong written communication skills
Self-starter with strong follow-through
Basic Qualifications:
High school/GED + 2 years’ work experience OR? Associates and 6 months’ work experience OR? Bachelors
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.