Empower CDS administration / support
Jobs via DiceGreenfield, IN, US1 day ago
Job type
- Full-time
Job descriptionEmpower 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, 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 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. Mid-Senior level Full-time Administrative Software Development
Overview
Fyntera IT Services is seeking candidates for a empower CDS administration and related responsibilities. Apply via Dice today!
Experience Range 8-12 years
Primary (Must have skills)
- 3+ years of hands-on experience in Empower CDS administration and support.
- 3+ years of experience on HPLC / UPLC 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
Seniorit y level
Employment type
Job function
Industries
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Administration Support • Greenfield, IN, US
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