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Position Title: Data Coordinator II
Work Location: Santa Clara, CA, 95050
Assignment Duration: 7+ Months
Work Schedule: M-F, 8-5pm
Work Arrangement: Onsite Position Summary:
Administration of program mechanisms: issuing reports for recall of precision measurement and test equipment, initiation of quality investigation forms associate with out of tolerance instruments, service scheduling between vendors and internal customers for onsite visits, and routine status communications to key stakeholders.
The scope of work encompasses Bay Area sites (Pleasanton and Santa Clara) with the primary work location in Santa Clara site. Key Responsibilities:
* Updates and maintains electronic and physical records of calibration for all laboratory instruments and equipment.
* Data processing and documentation review of calibration and qualification (commissioning and validation) records.
* Calibration and maintenance data entry into asset management databases (Blue Mountain Regulatory Asset Manager (RAM), SAP, and ASPIRE related databases).
* Generates routine calibration and maintenance recall/status reports.
* Induction and tracking of assets into various asset management systems.
* Performs shipping, receiving, and tracking tasks for laboratory instruments and equipment sent for calibration services to external vendors.
* Tracks and gathers data associated with Purchase Orders, costs, and other metrics.
* Schedules external vendor services for calibration and qualification events.
* Provides vendor escort into controlled laboratory spaces.
* Support internal & external audits.
* Support projects (Data Dashboard/KPI), data analysis, data collection and integration, and reporting.
* Other duties as assigned. Qualification & Experience:
* Associates or Bachelor's degree with minimum 5 year of experience in biopharmaceutical, biotech, and/or medical device industry
* Strong written (i.e. email correspondence) and oral communication skills
* Proficient in use and application of Microsoft Office software (Excel) and Google Suite applications (gSheet)
* Experience with asset management platforms is highly preferred
* Experience working with laboratory instrumentation, calibration, and qualification are highly preferred
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