Empower CDS administration
2 days ago
Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.
3+ years of hands-on experience in Empower CDS administration and support.
3+ years of experience on HPLC/UPLC/GC and other analytical instrument integration.
3+ years of experience on Computer System Validation (CSV) and preparation of validation deliverables.
1+ year on GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and Data Integrity requirements.
Key Responsibilities
Empower Administration & Support
Manage user accounts, access rights, roles, and privileges in Empower.
Perform system configuration, project management, and template/report customization.
Provide day-to-day L2/L3 support for Empower users across QC/analytical labs.
Instrument Integration & Troubleshooting
Integrate lab instruments (HPLC, UPLC, GC, Dissolution, UV, etc.) with Empower.
Troubleshoot connectivity, data acquisition, and communication issues between instruments and CDS.
Work with vendors (e.g., Waters, Agilent, Thermo) for resolution of technical issues.
System Validation & Compliance
Support Computer System Validation (CSV) activities for Empower and integrated lab systems.
Develop and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ, Test Scripts, Traceability Matrix).
Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs.
Participate in audits and inspections, providing system and compliance evidence.
Compliance & Lifecycle Management
Maintain audit trails, backup, archival, and disaster recovery procedures.
Conduct periodic system reviews and ensure alignment with regulatory requirements.
Collaborate with QA, IT, and Lab teams to manage change control and deviations.
Training & Continuous Improvement
Train and mentor lab users on Empower functionalities and best practices.
Propose process improvements for data integrity, system efficiency, and compliance.
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