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Quality Assurance Analyst
Contract: Thousand Oaks, California, US span>
Salary Range: 40.00 - 44.00 | Per Hour
Job Code: 367111
End Date: 2026-02-21
Days Left: 27 days, 4 hours left
About Role:
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This role supports the implementation of fully electronic lab notebook (ELN) system, focusing on system design, configuration, validation, and deployment in a regulated GxP environment.
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It is a non-laboratory, quality systems role that ensures ELN processes, documentation, and workflows comply with cGMP, CFR, and data integrity requirements.
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The position works cross-functionally with QC, QA, IT, validation teams, and site SMEs to deliver project milestones under BPO and project management supervision.
Responsibilities:
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Participate in process engineering activities to define and implement new ELN workflows aligned with business and quality requirements.
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Support system requirements gathering, software configuration, and design activities for the ELN platform.
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Facilitate the development and revision of SOPs, work instructions, forms, and manuals associated with new ELN processes.
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Receive, recreate, migrate, and verify master data required for site implementation and production deployment.
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Coordinate ELN template development and review with site Subject Matter Experts (SMEs).
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Support the development, execution, and review of Operational Qualifications (OQ) documentation.
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Execute User Acceptance Testing (UAT) and data migration verification to ensure system readiness and compliance.
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Review, provide input on, and support the development of training materials, and assist with instrument qualification planning and execution as needed.
Job Requirement
- ELN
- cGMP
- GMP
- SOP
- QC
- QA
- GxP
- migration
- Electronic Lab Notebook
- Pharmaceutical
Reach Out to a Recruiter
- Recruiter
- Phone
- Prathmesh Rathod
- prathmesh.rathod@collabera.com