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* Audits protocols, amendments, raw data, reports and supporting documentation for internal accuracy, consistency, and conformance with regulations and internal SOPs. * Evaluates interdepartmental processes for improvement opportunities and proposes solutions. * Helps design and develop risk-managed regulatory processes. * Oversees and designs training systems; acts as a lead trainer for new and junior staff. * Performs phase inspections of ongoing study activities. * Performs facility audits to ensure departmental compliance with the regulations. * Hosts regulatory client inspections and FDA inspections. * Performs GLP compliance inspections of external subcontractors.

* Audit GLP final reports, raw data and supporting documentation. * Perform phase inspections of study activities and facility procedures. * Review Standard Operating Procedures for GLP compliance. * Assist in the performance of computerized system validation inspections.

* Audit GLP final reports, raw data and supporting documentation. * Perform phase inspections of study activities and facility procedures. * Review Standard Operating Procedures for GLP compliance. * Assist in the performance of computerized system validation inspections.

* Manage and review laboratory data ensuring completeness and compliance to GLP regulations. * Perform verification of raw data for inclusion into study reports. * Coordinate efforts between department staff to respond to audits. * Monitor and communicate study deadlines to ensure adherence to set timelines.

* Perform specimen storage and retrieval. * Perform GLP compliance data entry. * Assist with maintaining study documents and records. * Assist with development of departmental Standard Operating Procedures

* Receive, log in, centrifuge, and prepare specimens according to SOPs and protocol design. * Perform GLP compliant data entry. * Perform specimen storage and retrieval. * Maintain inventory for laboratory supplies.

* Performs audits of equipment qualification and computerized systems validation projects for accuracy, consistency and conformance with 21 CFR Part 58 and 21 CFR Part 11 and company Standard Operating Procedure requirements. * Performs periodic audits of ongoing software program use, maintenance and change management to ensure continued conformance with 21 CFR Part 58 and 21 CFR Part 11 and company Standard Operating Procedure requirements. * Participates in Computerized System Vendor/Supplier audits to help determine the suitability of the vendor’s quality management system, system development practices, system testing/ release/ maintenance practices, system/data security practices, data management practices, and overall customer support. * Performs facility audits to ensure departmental compliance with the regulations. * Prepares, issues, and tracks reports of observations noted during audits and inspections. * Applies expertise to help solve compliance issues and meet company objectives by using root cause analysis techniques.

Bachelor of Science, Biology-Physiology at University of Washington