Empower CDS Administration Support Lead - Alameda, CA - Full Time

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Our client seeks an Empower CDS Administration Support Lead for a Full Time project in Alameda, CA . Below is the detailed requirement

Job Title : Empower CDS Administration Support Lead

Work location : Alameda, CA

Duration : Full Time (Permanent)

Job Description :

• Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT discipline or equivalent experience with 12+ Minimum Experience
• 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