The Quality Specialist ensures that all operations covered by the Third-Party Logistics provider (3PL) are conducted in full compliance with local regulations (including COFEPRIS), general CSL Behring policies, and current Good Distribution Practices (cGDPs). The role safeguards product quality integrity throughout the supply, storage, and distribution chain.
REPORTING RELATIONSHIPS
- Reports to: Local Quality Officer
- Direct Reports: None

Main Responsibilities & Accountabilities
- Product Reception at 3PL
- Supervise product reception at the 3PL in accordance with procedures, quality agreements, and applicable policies.
- Review artwork and labels of packaging materials and validate temperature records (data loggers).
- Oversee self-sampling processes in compliance with COFEPRIS-authorized procedures.
- Documentation Management
- Ensure all 3PL procedures and documents impacting CSL Behring products align with CSL Behring requirements.
- Verify that documentation generated during 3PL operations complies with Good Documentation Practices, quality agreements,



and applicable policies.
- Transport Release
- Review and evaluate temperature records during transportation from Source of Manufacturing (SoM) to 3PL and during local distribution.
- Perform formal Transport Release (TVF).
- Cold Chain Management
- Monitor compliance with product temperature specifications at the 3PL and during local distribution, ensuring data loggers are included in all shipments.
- Support customers in the event of temperature excursions.
- Manage temperature excursion events within 3PL operations.
- Ensure qualification and/or validation of transport and passive packaging from SoM to 3PL, from 3PL to customers, and from 3PL to analysis laboratories.
- Review and support testing of the 3PL cold room qualification.
- Quality Assurance (QA)
- Submit product analysis requests to the analysis laboratory and coordinate sample collection.
- Administer reference standards in accordance with proced

📌 Quality Specialist (Morelia)
🏢 Csl
📍 Morelia