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.

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.

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