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 crossâfunctional 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 LIMSârelated 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 systemârelated 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.
- Identify opportunities for process improvement and drive continuous enhancements in LIMS design and usage.
- Develop and deliver training for LIMS users at various proficiency levels.
- Collaborate closely with microbiology and chemistry laboratories and other site functions to support Change Management Processes (CMPs) and systemârelated quality initiatives.
- Partner with internal stakeholders to ensure LIMS supports operational efficiency and evolving business needs.
Qualifications
- Bachelorâs degree in Microbiology, Biotechnology, Chemistry, Biology, or a related scientific field; equivalent (4 years) industry experience will in a regulated laboratory or quality environment may be considered.
- English proficiency: Advanced
- Advanced working knowledge of LIMS (Laboratory Information Management Systems), including system administration, configuration, data management.
- Strong proficiency in Microsoft Office tools.
- Solid understanding of industry regulations related to GMP, GDP, and GLP.
- Experience in system validation, data management, and quality documentation.
- Experience in the medical device, pharmaceutical, or regulated laboratory industry preferred.
- Familiarity with microbiology or chemistry laboratory practices preferred.
What is expected of you and others at this level
- Exceptional attention to detail and commitment to data integrity.
- Strong verbal communication and interpersonal skills.
- Ability to work independently and collaboratively with crossâfunctional teams.
- Effective time management with the ability to manage multiple priorities.
- Ability to proactively identify and resolve issues.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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