Seeking Regulatory Assistant for medical device research facility.
SPECIFIC DUTIES AND RESPONSIBILITIES:
Support and participate in all IACUC duties including:
- Screen protocols for completeness
- Assist clients when necessary on protocol development
- Distribute amendments and deviations as needed
- Prepare agendas and distribute protocols and other materials to IACUC members
- Send out annual progress report reminders to client
- Send out approval letters to clients
- Review all documentation before submitting to QA
- Maintain records of protocols and IACUC minutes of meetings
- Maintain records of procedures, program reviews and facility inspection reports
- Coordinate and schedule the IACUC monthly meetings
Maintain Quality Program
- Be involved in improving processes and implementation via SOP review, random document review, walkthrough, feedback from management, etc.
- Spot check animal holding facilities to verify all documentation during ongoing projects
- Serving as an information resource for investigators and IACUC members regarding status of protocols and GLP studies
- Support equipment scheduling calibration & maintenance program, maintain records
In addition to the above, the position is required to support the GLP Program as needed within the following areas:
NIH/IACUC - assurance requirements
USDA - bi-annual audits - unscheduled audits - license requirements
QA: - GLP Project notebook (Master Schedule), QA audits - Quarterly internal business unit/facility audits - Water quality monitoring - Equipment: oversight of scheduling calibration & maintenance, maintain records - Support GLP Report compilation and associated functions related to compilation (archiving, review, etc.) - Act as a member of QAU SOP: - document control - processing
Special Factors: Must be able to work independently, exercise good judgment, and use diplomacy and tact in dealing with internal and external customers. Background or coursework in quality assurance a plus.
Local Candidates Only, no relocation
Role: Regulatory Assistant
Location: San Carlos,
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