Allison Iles Email & Phone Number

• Maintain and lead continuous improvement activities for the electronic Quality Management System (eQMS), ensuring the system meets current regulatory standards and operational needs.• Serve as the primary point of contact for quality and regulatory inquiries, providing expert guidance and support to internal teams and external partners.• Oversee the quality assurance aspects of clinical trials, from protocol development through to data analysis and reporting, ensuring compliance with Good Clinical Practice (GCP), ICH E6, and other regulatory standards.• Lead vendor assessments and audits to ensure compliance with quality standards and regulatory requirements and maintain an updated approved vendor list.• Perform ongoing vendor monitoring to keep track of complaints and vendor quality issues.• Conduct detailed risk assessments and manage the Corrective and Preventive Action (CAPA) system specifically for clinical trials, addressing any incidents, deviations, or non-conformances.• Support and carry out internal audit activities as per the established schedule.• Support/lead sponsor and regulatory audits/inspections, ensuring readiness and compliance across clinical trials operations.• Provide on-site audit support when needed.• Coordinate/support all QA training related activities within Cogstate.

Syracuse, New York, United States

• Ensure company-wide understanding of regulatory requirements including 21 CFR Part 820and ISO 13485 controlled manufacturing practices and quality standards, as well as CLIArequirements and quality standards.• Lead in the generation of investigations (non-conformances and customer feedback), rootcause analysis, and corrective and preventive action (CAPA) plans for commercial productsand laboratory related deviations.• Maintain a state of inspection readiness and provide leadership and audit management duringagency surveys or inspections.• Execute internal QMS audits to ensure compliance.• Promote continuous improvement of the Quality Management System, including but not limitedto processes for change control, document management, quality and management review,validation, and training.• Prepare regulatory submissions.• Assist in design control and risk management processes in collaboration with cross-functionalteam.• Certifications: ISO 13485 Internal Auditor.

Syracuse, New York, United States

• Participate in investigations, root cause analysis, and CAPA plans related to process andproduct deviations.• Generate and review change control documents and impact assessments to ensurecompliance.• Contribute to on-site FDA inspection and ISO 13485 certification audit.• Write and/or contribute to the creation or revision of standard operating procedures.• Support transition from paper-based to electronic quality management system (eQMS).

Syracuse, New York Area

• Manage internal and external site coordination including recruitment, data collection, andoutreach for autism spectrum disorder and mild traumatic brain injury studies.• Conduct internal study appointments and adhere to laboratory protocols for wastewatersurveillance and saliva pooling laboratories.

Syracuse, New York Area

• Administer therapy sessions with children seeking behavioral or feeding treatment.• Aid primary therapist in graphing data, writing client progress notes, and creatingprotocols.

Syracuse, New York

• Process and organize confidential student information using Microsoft Excel and Datatel.• Answer phone inquiries, make appointments, and other clerical work as needed.

Fairmount, Ny

• Greet customers upon arrival.• Organize seating rotation in the restaurant and seated customers.

Bachelor Of Science (B.S.), Psychology, Overall Gpa 3.693, Major Gpa 3.968

Activities and Societies: Captain of the Women's Indoor Track and Field and Outdoor Track and Field teams, Psi Chi National Honor Society.

High School Diploma With Advanced Designation

Activities and Societies: Cross Country, Indoor Track and Field, Outdoor Track and Field, National Honor Society, Student Senate