Job Title: Supply Chain Sr. Associate
Duration: 12 Months (Possible extension)
Location: Remote
Remote candidates: Manager prefers the West Coast time zone.
Work Schedule: 8:00 AM - 5:00 PM; some OT is anticipated.
Position Summary
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.
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
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
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.
- 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.
Possible Extension:
Yes
Red Flags:
N/A
Interview Process:
Phone, ASAP
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Spectraforce Technologies
Aug 04, 2026