Data Coordinator II

Job Title: Data Coordinator II - Calibration & Qualification
Location: Bay Area Sites (Pleasanton and Santa Clara)

Position Summary
The Data Coordinator II will join a growing team dedicated to database management, documentation processing, and vendor scheduling/management essential to the calibration and qualification of laboratory instruments and equipment.

Essential Functions

• 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.
• 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 and other data integration as applicable.
• Other duties as assigned.

Minimum Qualifications
Education & Experience:

• Associates or Bachelor s degree with minimum 1 year of experience in biopharmaceutical, biotech, and/or medical device industry

Knowledge, Skills, and Abilities:

• 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