Job Description

Location: Hybrid - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $35/$39 per hour (based on experience)

of the Role

Join a large biotech pharmaceutical leader as a Supply Chain Sr Associate supporting transportation qualification and cold chain initiatives. This hybrid role partners closely with Quality, Thermal Engineering, Manufacturing, and Supply Chain to ensure compliant distribution of temperature-sensitive materials. You will execute studies, maintain controlled documentation, and support regulatory submissions in a highly regulated environment.

Key Responsibilities

• Support execution of transportation qualification studies alongside 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
• Assist with deviation investigations, change controls, and CAPA documentation related to transport activities
• Prepare documentation for Marketing Authorization Applications (MAA) and regulatory inquiries
• Maintain transportation SOPs and controlled documents to ensure GMP/GDP compliance
• Collaborate with Quality and Thermal Engineering 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 multiple transportation studies at varying lifecycle phases and drive continuous improvement projects

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 abilities
• Analytical skills for translating complex information into actionable insights
• Proficiency with Microsoft Excel, Word, and PowerPoint
• Detail-oriented and compliance-focused
• Strong written communication skills
• Flexible and able to manage shifting priorities
• Self-starter with strong follow-through

Preferred Qualifications

• Experience with cold chain, validation, or quality systems
• Familiarity with deviation, CAPA, and change control processes
• Background in cross-functional team environments
• Familiarity with parcel, transport, and warehousing provider operations
• Ability to independently interact at various levels and drive tasks to completion
• Strong negotiation and problem-solving abilities

Top 3 Must Have Skills

1. Supply Chain

2. Scientific

3. Quality

Day-to-Day Responsibilities

• Execute transportation qualification studies
• Coordinate with Thermal Engineering Labs and Sample Management
• Analyze and organize shipment data and temperature monitoring results
• Draft and maintain protocols, reports, and supporting documentation
• Contribute to investigations and documentation for regulatory submissions
• Manage timelines and support multiple concurrent studies

Basic Qualifications

• High school/GED + 2 years work experience
• Associates and 6 months work experience
• Bachelors

This posting is for Contingent Worker, not an FTE