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), global CSL Behring policies, and current Good Distribution Practices (cGDPs). The role safeguards product quality integrity throughout the supply, storage, and distribution chain.
- Reports to: Local Quality Officer
- Direct Reports: None
1. 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.
2. 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.
3. 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).
4. 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.
5. Quality Assurance (QA)
- Submit product analysis requests to the analysis laboratory and coordinate sample collection.
- Administer reference standards in accordance with procedures, quality agreements, and applicable policies.
- Review Certificates of Analysis (CoA) issued by the analysis laboratory.
- Ensure retention sample management for CSL Behring products meets internal requirements.
- Coordinate delivery of Certificates of Analysis to Customer Services per applicable requirements.
6. Product Returns
- Conduct returned product inspections.
- Execute SAP transactions in accordance with return assessment outcomes.
- Notify relevant CSL Behring and 3PL stakeholders of return destinations.
7. Quality Systems Support
- Support quality system processes including: Complaints, Counterfeits, Deviations, CAPAs, Documentation, Product Recall, Annual Product Reviews, Product Release, and Change Control.
- Operate computerized Quality Management Systems: TrackWise, Veeva, and Plateau.
Education
- Master, Bachelor, or equivalent degree in life-sciences (Pharmacy Preferred)
Experience
- Minimum 4 years of professional experience in Quality in a multinational innovative pharmaceutic al company.
- Management of quality electronic systems (TrackWise, VeeVa, etc.)
- ERP Management (SAP)
Competencies
- Target oriented and ability to work under pressure to meet deadlines and qualitative objectives.
- Strong interpersonal skills
- Good negotiation and communication skills
- A character of loyalty and integrity
- Fluent in English and Spanish (speaking and writing)
ADDITIONAL NOTES
The majority of activities will be performed at 3PL facilities. The Quality Specialist may also be required to conduct activities at CSL Behring Mexico offices as business needs dictate.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
