Description
Major Duties and Responsibilities:- Manage the Calibration database and schedule; Complete daily updates ensure timely entry of data; notify department contacts of pending calibration and "Out of Tolerance" events, Interface with the Calibration Service provider to ensure timely calibration and reporting of "Out of Tolerance" events, Review Certificates of Calibration, "Out of Tolerance" reports and other program related documents for equipment calibration; ensure that appropriate corrective/preventive measures are taken as needed and maintain the calibration files.
- Review environmental monitoring data for Relative Humidity, Temperature and Pressure differentials. Review and approve "Out of Limit" reports for environmental and Storage unit (freezers, refrigerators, cold rooms etc.) monitoring; ensure that appropriate corrective/preventive measures are taken and maintain Environmental Monitoring records.
- Review and approve validation protocols and reports as required to ensure compliance with site Master Validation Plan, schedule and corresponding procedures; Ensure robust equipment qualification, product and process validation protocols and reports are completed.
- Utilize databases to collect data. Analyze data statistically and present it in comprehensible format for discussions (capability, trend and Pareto charts). Generate reports in support of Manufacturing, Development and Quality Assurance (including for Management Reviews).
- Investigate assigned CAPAs to root cause, ensuring that appropriate corrective and preventive action is taken for timely and effective closure to issue.
- Initiate deviations as needed and drive corrective actions to effective resolution.
- Quality System Improvement projects, as assigned.
Requirements:
- B.S. in a scientific discipline
- 0 - 2 years in FDA regulated/medical device industry.
- Demonstrated knowledge related to FDA guidance documents.
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