Integrated Resources INC
Quality Systems Specialist
Foster City, CA, United States · Mid
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About the role
- Development and generation of weekly/monthly QA group metrics.
- Performing first line review of unscheduled Maximo work orders and equipment job plans.
Responsibilities
- Development and generation of weekly/monthly QA group metrics. The metrics tracked will be validation document turnaround, Quality System records turnaround, and other group throughput data.
- Performing quality reviews of validation life cycle documents such as system impact assessments, equipment risk assessments, user and functional requirements specifications, validation protocols and reports.
Requirements
- The resource should have a working knowledge of key concepts that are required for GMP compliant standard operational procedures.
- The resource will be required to understand basic GMP requirements for calibration and maintenance of GMP utility and support systems such as HVAC, qualified gas systems, and purified/ distilled water systems.
Nice to have
- The resource should have 2-3 years of prior experience in a regulated cGMP environment.
- Prior experience in the pharmaceutical /biotech sector is preferred.
- Additional proficiency in the use of Excel, PowerPoint, Maximo, and TrackWise software is needed.
This listing is sourced directly from Integrated Resources INC's careers page and normalized into a canonical job model.