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Numbers & Facts
Location
Thousand Oaks, California, United States, CA
Salary
$35–$37 Per Hour
Description
Payrate: $35.00 - $37.00/hr.
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.
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
Pay Transparency: The typical base pay for this role across the U.S. is: $35.00 - $37.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary. You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
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