Location:Remote - Thousand Oaks, CA (PST preferred)
Employment Type: Contingent Worker (Contract, W2)
Contract Length: 12 months (possible extension)
Compensation: $35/$39 per hour (based on experience)
Summary of the Role
Join a large biotech pharmaceutical leader’s supply chain team as a Sr Associate focused on transportation qualification and cold chain activities for temperature-sensitive materials. Work cross-functionally to execute, document, and ensure compliance in distribution processes, supporting both study activities and regulatory documentation. This role offers a dynamic environment with opportunities to drive process improvements and ensure product quality.
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
- Draft qualification protocols and reports; gather, analyze, and interpret data
- Support deviation investigations, change controls, and CAPA documentation related to transport activities
- Draft documentation to support Marketing Authorization Applications (MAA) and respond to regulatory inquiries
- Maintain transportation SOPs and controlled documents in compliance with GMP/GDP requirements
- Collaborate with Quality and Thermal Engineering teams to interpret data and ensure inspection-ready documentation
- Track qualification timelines and support cross-functional project coordination
- Perform shipment performance trending and support risk assessments
- Manage and support multiple transportation studies at different lifecycle phases
- Contribute to and drive continuous improvement projects in cross-functional collaboration
Required Experience & Skills
- 0–3 years’ 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 and drive tasks to completion
- Strong negotiation and problem-solving skills
Top 3 Must Have Skills
1. Strong documentation and organizational skills
2. Strong analytical skills with the ability to turn complex information into clear, practical insights
3. Proficiency in Microsoft Excel, Word, and PowerPoint
Day-to-Day 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
- Draft qualification protocols and reports; perform data gathering, analysis, and interpretation
- Support deviation investigations, change controls, and CAPA documentation related to transport activities
- Draft 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
- High school/GED + 2 years work experience
- Associates degree and 6 months work experience
- Bachelors degree
This posting is for Contingent Worker, not an FTE