Cold Chain & Packaging Specialist

Job Description

Description:

Position Summary

The Cold Chain & Packaging Specialist is responsible for managing and maintaining all temperature monitoring, calibration, and packaging validation activities across Gifthealth’s pharmacy and distribution facilities. This role ensures that all temperature-sensitive products are stored, packaged, and shipped in compliance with URAC, FDA, BOP, and ISTA standards, while maintaining documentation and readiness for audits and accreditation reviews.

The specialist will lead all calibration of temperature sensors, investigate and document temperature excursions, coordinate packaging validation testing, and source new packaging materials for cold chain and ambient products. This individual will work cross-functionally with Supply Chain, Compliance, and Operations teams to ensure packaging systems meet regulatory and manufacturer quality requirements.

Key Responsibilities

Temperature Monitoring & Calibration

Perform regular calibration of all temperature sensors across all Gifthealth locations, ensuring accuracy and regulatory compliance.

Monitor daily temperature logs and investigate any high or low temperature alarms, documenting root cause and corrective actions.

Determine whether excursions require escalation to leadership or reporting per SOPs.

Maintain detailed calibration, maintenance, and investigation records in accordance with URAC and accreditation requirements.

Coordinate with Facilities and Operations to ensure proper sensor placement, accuracy, and alarm functionality.

Packaging Management & Validation

Source, qualify, and manage all cold chain and ambient packaging used for shipping pharmaceutical products.

Collaborate with the Supply Chain Manager and manufacturer quality teams to ensure all packaging meets regulatory and quality approval standards.

Conduct triplicate packaging validation testing at least twice yearly (or as required by accreditation standards) for all facilities.

Manage and document results for ISTA 3A and ISTA 7E testing, ensuring clear pass/fail results are recorded and reported.

Maintain certification and validation records for all packaging configurations, including seasonal (summer and winter) pack-out designs.

Testing & Compliance

Understand and apply URAC, UPS Mail Order/Delivery, BOP, and ISTA regulatory standards.

Ensure all packaging validation testing is complete prior to product launches, new packaging implementation, or seasonal transitions.

Collaborate with Compliance and Quality teams to confirm packaging and temperature monitoring systems meet accreditation requirements.

Stay informed of updates to URAC, ISTA, and other standards to ensure ongoing compliance and testing updates as requirements evolve.

Assist in audits, inspections, and quality reviews related to temperature control and packaging validation.

Cross-Functional Collaboration

Work with Supply Chain and Operations leadership to plan and implement packaging changes, equipment upgrades, and testing schedules.

Collaborate with Compliance to ensure timely documentation of all test results, failures, and corrective actions.

Communicate testing outcomes, investigation summaries, and improvement recommendations to senior leadership.

Support engineering and process improvement teams in developing new packaging designs and temperature monitoring solutions.

Key Competencies

Technical Proficiency: Skilled in temperature monitoring systems, calibration tools, validation testing, and cold chain data loggers.

Regulatory Knowledge: Strong understanding of URAC, BOP, FDA, and ISTA 3A/7E testing standards.

Analytical Thinking: Ability to analyze temperature data, determine root causes, and recommend corrective actions.

Attention to Detail: Maintains precise documentation and adheres to all validation and compliance protocols.

Collaboration: Works effectively with Supply Chain, Compliance, and Operations teams to maintain quality standards.

Accountability: Takes ownership of compliance testing, results accuracy, and packaging readiness.

Continuous Improvement: Proactively identifies process enhancements for packaging efficiency and reliability.

Qualifications

Bachelor’s degree in Supply Chain, Quality Assurance, Life Sciences, or a related field preferred (or equivalent experience).

Minimum 3+ years of experience in cold chain logistics, packaging validation, or pharmaceutical distribution operations.

Demonstrated experience with temperature monitoring systems and calibration procedures.

Familiarity with ISTA 3A, ISTA 7E, and URAC accreditation requirements.

Experience coordinating testing with third-party validation labs preferred.

Strong organizational and documentation skills with the ability to manage multiple testing schedules.

Proficient in Microsoft Office, Excel, and data reporting systems.

Excellent communication and analytical problem-solving skills.

Work Environment

Location: On-site

Schedule: Full-time

May require additional availability or flexibility for escalations.

Regular meetings with teams, departments, or leadership to ensure alignment.

Physical Requirements:

Ability to lift and move up to 50 lbs as needed for equipment or packaging setup.

Comfortable working in temperature-controlled environments (cold, ambient, and freezer areas).

Ability to stand, walk, and handle testing materials for extended periods.

Employment Classification

Status: Full-Time

FLSA: Exempt

Equal Employment Opportunity (EEO) Statement

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.

Requirements:

Full-time