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
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $34.00/hr - $40.47/hr.
