The SampleManager LIMS Administrator is responsible for the ongoing administration, configuration, maintenance, and validation of the Thermo Scientific SampleManager Laboratory Information Management System (LIMS) in a regulated pharmaceutical environment. This role serves as the primary technical resource for the LIMS platform, ensuring system availability, data integrity, and compliance with applicable regulatory standards including 21 CFR Part 11, GxP, and corporate quality policies.
Responsibilities:
System Administration & Configuration
Administer, configure, and maintain SampleManager LIMS including user accounts, roles, security groups, and access controls.
Manage system configuration including sample templates, workflows, login forms, scheduled jobs, and report layouts.
Monitor system performance, availability, and capacity; coordinate with IT infrastructure teams on server maintenance and upgrades.
Perform routine system health checks, backups, and disaster recovery testing in accordance with IT policies.
Manage SampleManager versioning, patch deployment, and planned upgrade activities in coordination with the vendor.
Troubleshoot and resolve system issues, escalating to Thermo Scientific support when necessary.
Maintain master data including units of measure, analysis definitions, product specifications, and instrument records.
Validation & Compliance (GxP / 21 CFR Part 11)
Author, execute, and maintain LIMS validation documentation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Ensure all system changes are managed through a formal change control process with supporting validation impact assessments.
Maintain audit trail integrity and periodically review audit trail records in compliance with 21 CFR Part 11 requirements.
Author and maintain system-related SOPs, work instructions, and validation documents.
Support internal audits and regulatory inspections, providing LIMS documentation and demonstrating system compliance.
Conduct periodic system reviews and revalidation activities as required by regulatory changes or significant system modifications.
Collaborate with Quality Assurance to ensure LIMS practices align with data integrity principles and ALCOA+ standards.
Participate in deviation investigations and CAPAs related to LIMS data or system issues.
User Support & Training
Provide Tier 1 and Tier 2 support to LIMS end users, resolving issues and escalating complex problems as appropriate.
Develop and deliver user training programs for new hires and on system updates; maintain training records in the LMS.
Projects & Continuous Improvement
Participate in LIMS-related projects including interface development, module implementations, and system integrations.
Evaluate and implement new SampleManager features or third-party integrations to improve laboratory efficiency.
Collaborate with laboratory stakeholders to gather requirements and translate them into system configurations.
Qualifications
Qualifications:
Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field.
Minimum of one year experience configuring or working within the development of SampleManager LIMS.
Demonstrated experience working in a GxP-regulated environment (pharmaceutical, biotech, or medical device).
Working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
Experience authoring and executing LIMS validation protocols (IQ/OQ/PQ) and change control documentation.
Experience with LIMS integrations (instruments, ERP, ELN, or other laboratory systems).
Knowledge of laboratory operations in a pharmaceutical QC, QA, or R&D environment.
Strong analytical and problem-solving skills with attention to detail.
Excellent written and verbal communication skills; ability to work effectively with both technical and non-technical stakeholders.
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