Ryan Mccarthy Email & Phone Number

Northfield, Illinois, United States

Plan, schedule and execute audits of domestic and international Medline suppliers. This includes a vast finished product portfolio (APIs, sterile products, medical devices, pharmaceuticals) as well as contract sterilizers, laboratories, and raw material suppliers. Evaluate supplier regulatory compliance in accordance with FDA regulations, ISO 13485, MDSAP, MDD/MDR and other global regulatory requirements. Assist in the evaluation of Medline suppliers to determine approval status.Plan, schedule and execute Medline internal audits (domestic and international) in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements.Responsible for observation/CAPA follow ups for both suppliers and internal audits.Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers.Manage and participate in quality initiatives to maintain and improve compliance. Such as evaluating internal processes and creating/revising applicable procedures and SOPs.Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications.

Mount Prospect, Il

Solely responsible for managing and executing the firm’s vendor management program which includes over 60 vendors (raw material, components, third-party laboratories). This includes vendor/raw material qualification for current drug products as well as R&D Drug products. On-Site, desktop and virtual audits performed. Verify USP compliance for applicable vendors. Solely responsible for managing and executing the firm’s internal audit program. Auditing of the firm’s two production facilities, ensuring adherence to industry standards. This includes Data Integrity focused audits, adherence to ALCOA. Responsible for the firms CAPA and SCAR program while working directly with vendors in cases of non-compliance. Creation and execution of effectiveness verification plans. Created and presented a quarterly CAPA Report to management outlining areas of concern that may require additional oversight.Responsible for evaluating all quality product complaints and reported adverse drug reactions.Managed the sites deviation program, utilizing a risk-based approach to determine possible impact to product SISPQ. Responsible for generating Risk Assessment and identifying risk reduction controls. Performed root cause analysis reports related to incident investigations, CAPA/SCARs and product complaints. Completed prior approval readiness audits of facility sites to ensure site and system is within compliance. Software Utilized: Site QMS (Salesforce), Microsoft Office Suite, Site ERP system (Sage 100)

Assisted in the review of data in relation to the facilities Environmental Monitoring program. Monitored data quantitatively and qualitatively. Qualitative data analyzed for objectionable organisms with supporting risk assessment documentation.Solely responsible for managing the firm’s internal audit program. Departmental and site audits performed. Assisted the QA manager in the CAPA and SCAR program. Monitor and reported data for quarterly reporting to management.

Mount Prospect, Il

Project manager-based role which included working with multiple departments, customers and suppliers for an effective and efficient change process while ensuring regulatory compliance and Xttrium standards.Managed the sites document control system (revise, file approve, and discontinue documents). This includes controlled documents, SOPs, specifications, production formulas and product label changes.

Mount Prospect, Illinois

Improved product quality by conducting thorough inspections and identifying defects in a timely manner.Inspected incoming and outgoing material for accuracy and quality.Responsible for managing and executing the facilities environmental monitoring program. Performed and responsible for batch record review and approval of product release to the marketplace.