Supply Chain Associate
Location: Remote - Thousand Oaks, CA (PST preferred)
Employment Type: Contingent Worker (Contract, W2)
Contract Length: 12 months (possible extension)
About the Role
Join a large biotech pharmaceutical leader as a Supply Chain Sr. Associate supporting transportation qualification and cold chain activities for temperature-sensitive materials. This role will support qualification studies, temperature monitoring data analysis, documentation, regulatory support, and GMP/GDP-compliant distribution processes. The ideal candidate brings strong documentation, analytical, and organizational skills, with the ability to support multiple transportation studies, collaborate cross-functionally, and help ensure inspection-ready documentation across cold chain and distribution activities.
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, reports, and supporting documentation
- Gather, analyze, and interpret data related to transportation studies and shipment performance
- Support deviation investigations, change controls, and CAPA documentation related to transport activities
- Draft documentation to support Marketing Authorization Applications and regulatory agency 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 transportation-related risk assessments
- Manage and support multiple transportation studies at different lifecycle phases
- Contribute to continuous improvement projects across cross-functional teams
Requirements
- 0-3 years of experience in pharmaceutical, biotech, manufacturing, or another regulated industry
- Understanding of GMP principles through academic or professional experience
- Strong documentation and organizational skills
- Strong analytical skills with the ability to translate complex information into clear, practical insights
- Proficiency in Microsoft Excel, Word, and PowerPoint
- Ability to support multiple priorities, timelines, and study activities simultaneously
- Strong attention to detail and commitment to compliant documentation
- Ability to collaborate with cross-functional partners across Quality, Thermal Engineering, Sample Management, and Supply Chain
- Strong communication, follow-up, and problem-solving skills
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
- 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
Day-to-Day Responsibilities
- Support transportation qualification studies and coordinate with Thermal Engineering Labs and Sample Management
- Collect, organize, and analyze temperature monitoring and shipment data
- Draft qualification protocols, reports, and supporting documentation
- Perform data gathering, analysis, and interpretation for transportation activities
- Support deviation investigations, change controls, and CAPA documentation
- Draft documentation for Marketing Authorization Applications and regulatory inquiries
- Maintain transportation SOPs and controlled documents in compliance with GMP/GDP standards
- Collaborate with Quality and Thermal Engineering teams to interpret data and maintain inspection-ready documentation
- Track qualification timelines and support cross-functional project coordination
- Perform shipment performance trending and support risk assessments
- Manage multiple transportation studies across different lifecycle phases
- Support continuous improvement projects related to transportation qualification and cold chain processes
Pay
$35–$39 per hour (based on experience)