Diana Lopez Email & Phone Number

Boston, Ma, Us

Framingham, Massachusetts, United States

Framingham, Massachusetts, United States

· Own, manage and execute change controls, deviations and CAPAs using Phenix and QualiPSO/VeevaVault systems· Facilitate problem solving meetings for deviations, change controls and document revisions· Lead cross-functional meetings for Root Cause Analysis, Change Controls, and SOP creation/revision· Investigate manufacturing and environmental quality events · Liaison with Metrology department to ensure equipment is calibrated in a timely manner; track maintenance and calibration of equipment on Gage Insite and Infor EAM· Assist in creating training curriculum for the department· Create, revise and review GMP documentation such as master production records, SOPs and forms · Create, maintain, and review logbooks/GMP documentation for equipment and facility cleaning· Train, manage, and coordinate a team for management of department logbooks/GMP documentation· Train manufacturing operators on initiating deviations· Participate in internal audits/self-inspections as the lead audit response coordinator· Represent the department at site quality meetings by providing updates on deviation and CAPA closure progress and support deviation closure metrics for KPIs· Support the manufacturing of cell therapy products for clinical supply such as receipt, inspection, and release of apheresis

Corona, California, United States

· Managed on-site quality operations and quality team (including training QA/RA specialists and delegating work)· Performed the duties of Senior Quality Assurance and Regulatory Compliance Specialist

· Review lab notebooks, batch records, and QC records in order to verify certificates of analysis and QA documentation for proper approval of the release and shipment of our products· Maintain vendor/supplier qualification, review material specifications, and effect proper QA release of materials received for in-house lab and production use· Review and revise our existing libraries of SOPs, Forms, and Product Information· Identify and draft new SOPs, Forms, validations, and other documents as needed to maintain adherence with ISO 9001 and compliance with applicable regulations· Implement/monitor/enforce lab policies, process improvements, environmental monitoring, GDP, and employee safety· Assist with managing/recording customer complaints and implementing appropriate corrective and preventive actions· Participate in conducting internal audits, preparing deviation reports, and investigating/documenting CAPAs as assigned· Work with scientists and production staff to continually improve compliance and documentation – to ensure quality and efficiency· Assist with drafting data capture tools and writing reports in support of regulatory submissions

Irvine, California, United States

· Conduct incoming, in-process, and final inspections of Class I/II medical devices (in-vitro diagnostics devices) to meet compliancy requirements including ISO, FDA and international regulations· Ensure timely release of products· Perform and document inspections on incoming parts· Perform and document in-process and final inspections of devices· Generate and maintain Certificates of Analysis for finished-kit products· Perform stability studies to verify expiration dates of products as stated· Use Agile to report nonconforming products· Perform and document equipment validation, calibration, and maintenance· Write Installation (IQ) and Operational Qualifications (OQ) for equipment validation· Perform and maintain device retention· Perform inventory and weekly/monthly reports of biological specimen and chemical controls· Collect, analyze, and interpret data for company projects, as assigned by management· Update and improve data and inventory logs kept on Excel· Conduct monthly audits and devise corrective measures as a member of Branan’s Safety Team· Ensure cleanliness and organization of the QC lab, according to 5S principles