Ashley Shockley Email and Phone Number

Management of potential suspected and suspected scientific misconduct and/or fraud cases including due diligence checks, notification and reporting requirements to appropriate internal and external parties and coordination of investigational activities. Plan and conduct regular and random QA audits of the ICON Quality System in order to assure compliance with applicable Good Clinical Practices, Good Laboratory Practices when applicable, relevant regulations, ICON SOPs and Sponsor requirements. Perform the role of lead auditor to assess the effectiveness of the Quality System and to verify that the Quality System is being implemented. Perform vendor and sub-contractor audits as well as assist with hosting Sponsor and/or FDA audits as required. Ensure that audit results and other quality information are formally and consistently reported and that corrective actions/preventive actions have been documented and followed up on effectively. Review and analyze audit metrics across the Quality and Compliance Department and assist with generating monthly and quarterly reports for Senior Management.

Implemented, maintained and enhanced quality procedures and systems to ensure compliance with FDA, OECD and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CRF Part 320, and other relevant guidances and publications. Ensured requirements and documentation for all regulated systems were kept current according to ever-changing guidelines and industry standards. Conducted QA audits of Bioanalytical laboratories and functions including but not limited to: in-process laboratory procedures, data review, method validation, equipment validation, technical reports and study independent facility/processes. Conducted QA audits of core processes which included sample management, equipment logbooks and calibration records. Effectively reported quality issues to the Director of Quality Assurance, Study Director and management, as appropriate. Provided oversight and input to investigations and CAPA, as appropriate.• Assisted the Director of Quality Assurance during 1 FDA inspection.• Assisted the Director of Quality Assurance during 6 Quality Assurance related external client audits.

Developed and validated semi-automated bioanalytical LC/MS/MS methods, in a GLP environment, which were used to analyze biological samples from FDA regulated and non-regulated studies for small molecules, as well as metabolites, in non-clinical and Phase I clinical development. Authored method validation and study reports which were used to support regulatory submissions and co-authored departmental Standard Operational Procedures (SOPs). Performed routine calibration and maintenance of mass spectrometers and liquid handling systems. Audited routinely by the Quality Assurance group in regards to sample handling, in-process procedures, equipment/instrumentation and report writing.Contributed to Phase 1 and Phase 1/2 clinical studies for an on-going oncology project. Communicated with multiple clinical scientists at various sites on a regular basis, in order to ensure proper documentation and compliance in regards to sample delivery, sample handling and sample analysis. Ensured accurate Electronic Data Transfer (EDT) from Watson LIMS database to a clinical database.Met and exceeded a critical time-line for method validation, clinical sample analysis and report issuances by utilizing the Aria LX4 and API Sciex 4000 to multiplex a LC/MS/MS method. Performed cross-validation, wrote the validation report and analyzed over 800 clinical samples in a 3 day time period.Served as a Sample Coordinator upon request. Received and checked-in samples into the Watson LIMS database, distributed samples to scientists, disposed samples upon completion of studies and shipped samples to off-site locations upon request.Selected to participate as a Tester during the validation process of the Electronic Laboratory Notebook system. Performed several validation scripts and acted as a "go-to" person when questions were raised by others in the department.