10 sep
|
Cardinal Health
|
Ciudad Juárez
10 sep
Cardinal Health
Ciudad Juárez
_What Sterility Assurance contributes to Cardinal Health_
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Sterility Assurance performs technical studies and specialized laboratory testing to ensure that the risk of microbial contamination in our medical device product is controlled and appropriately low in our sterile product.
The Sterility Assurance LIMS Administrator is responsible for the oversight, maintenance, and continuous improvement of the Laboratory Information Management System (LIMS) used within Sterility Assurance. This role ensures the system is configured, validated, and functioning in alignment with regulatory, quality, and operational requirements. The LIMS Administrator partners closely with cross‑functional teams to support data integrity, system usability, and seamless laboratory operations across multiple sites in LATAM and USA.
_ Accountabilities_
- Administer, configure,
and maintain all aspects of the LIMS platform to ensure consistent functionality and data integrity.
- Manage user accounts, roles, permissions, and workflows.
- Coordinate LIMS setup and onboarding for new users and new site implementations.
- Perform required system upgrades, patches, and enhancements in collaboration with IT and vendor resources.
- Lead and execute LIMS‑related validations, including OQ/PQ activities.
- Ensure the system remains compliant with GMP, GDP, GLP, data integrity principles, and applicable regulatory expectations.
- Maintain and author controlled documentation, including procedures, policies, work instructions, forms, and training materials.
- Ensure adherence to Good Documentation Practices (GDP) in all system‑related activities.
- Serve as the primary contact for system troubleshooting and issue resolution across multiple sites.
- Manage nonconformances, deviations, and investigations related to LIMS performance or data integrity.
📌 Sterility Assurance Lims Administrator (Ciudad Juárez)
🏢 Cardinal Health
📍 Ciudad Juárez