Michelle Frese Email & Phone Number

South San Francisco, California, United States

· Support configuration, validation, and launch of electronic quality system (EQMS): - Configuration: Provide support with configuring eQMS modules to meet company needs. - Validation Support: Assist with developing and executing test scripts. Provide validation support. - Cross-Functional Collaboration: Collaborate closely with cross-functional teams, gather system requirements, troubleshoot issues, and ensure alignment with business objectives. - System… Show more · Support configuration, validation, and launch of electronic quality system (EQMS): - Configuration: Provide support with configuring eQMS modules to meet company needs. - Validation Support: Assist with developing and executing test scripts. Provide validation support. - Cross-Functional Collaboration: Collaborate closely with cross-functional teams, gather system requirements, troubleshoot issues, and ensure alignment with business objectives. - System Expertise: Utilize my extensive knowledge to enhance system performance and user experience. - Change Management: Assist with change management processes to ensure smooth transitions during system updates and configurations. - Documentation: Maintain accurate documentation of processes, user work instructions, and configurations to support compliance requirements. - Communication: Working between QA CSV team, QA, GMP, and Clinical, as well as coordinating with business leaders.· Optimize and Manage GxP Electronic Document Management System (EDMS): - Manage document workflows from creation, revision, approval, and archival status. - Troubleshoot system errors. - Manage Periodic Review of documents.· System Administrator for Veeva and MasterControl.· Manage document control process for SOPs, work instructions, policies, specifications, and training material.· Manage CAPA, Deviation, and Change Control systems to ensure timely closure. · Assist with Quality System process improvements. Show less

Brisbane, California, United States

· Assist with the implementation and global management of electronic quality management systems(Veeva, ComplianceWire).· Management oversight to the QA Document Control staff to ensure organization and management of GxP documentation.· Manage GMP reports and records.· Management oversight to the QA Document Control staff to ensure preparation and revision of Sangamo SOPs, Material Specifications and other manufacturing and QA documents. · Global management and… Show more · Assist with the implementation and global management of electronic quality management systems(Veeva, ComplianceWire).· Management oversight to the QA Document Control staff to ensure organization and management of GxP documentation.· Manage GMP reports and records.· Management oversight to the QA Document Control staff to ensure preparation and revision of Sangamo SOPs, Material Specifications and other manufacturing and QA documents. · Global management and oversight of the training program/ training systems for all GxP employees. · Assist with creation and maintenance of training curriculums. · Manage training assignments and retraining in ComplianceWire. · Implement procedural quizzes.· Assist with system configuration changes (Change controls, Protocol creation and executions, Training end users on changes, etc.)· Support GxP functions through the deployment of quality systems.· Assist with impact assessments and closure of change actions.· Support internal and external audits.· Issue and maintain quality system tracking mechanisms, logs and job specific metrics. Show less

San Francisco, Ca

· Assist with maintaining the Quality Management System (QMS) for compliance· Oversee and manage the EDMS (Electronic Management System) and workflow process· Ensure Good Documentation Practices (GDP) are followed· Manage the Learning Management System (LMS) for Quality and EHS training companywide· Manage the NCR, CAPA, and complaint tracking system· Assist with maintaining the following ISO 9001 and 13485 QMS processes for compliance: · Risk assessments ·… Show more · Assist with maintaining the Quality Management System (QMS) for compliance· Oversee and manage the EDMS (Electronic Management System) and workflow process· Ensure Good Documentation Practices (GDP) are followed· Manage the Learning Management System (LMS) for Quality and EHS training companywide· Manage the NCR, CAPA, and complaint tracking system· Assist with maintaining the following ISO 9001 and 13485 QMS processes for compliance: · Risk assessments · Internal auditing · Configuration Changes · Change Control · Process Improvement· Assist with Supplier Quality: · Supplier Risk Assessments · Supplier Surveys · Supplier Evaluation · Updating Approved Supplier List (ASL)· Generate QMS KPI reports· Manage part number request process Show less

San Francisco, Ca

· Assist with implementing a Quality Management System for ISO 9001 and 13485 certification· Implement and manage ISO 9001 and 13485 QMS processes: · Risk assessment · Internal auditing · Nonconformance's, CAPA's, and complaints · Change Control · Document Control · Software Validation · Quality Management System metrics · Supplier Quality · Training · Process improvements · Assist with Process… Show more · Assist with implementing a Quality Management System for ISO 9001 and 13485 certification· Implement and manage ISO 9001 and 13485 QMS processes: · Risk assessment · Internal auditing · Nonconformance's, CAPA's, and complaints · Change Control · Document Control · Software Validation · Quality Management System metrics · Supplier Quality · Training · Process improvements · Assist with Process Validation · Perform incoming raw material C of A inspection · Establish and maintain a EDMS that meets ISO 9001:2015 and 13485:2016 requirements· Manage document workflows for collaboration, approval, training, and published states Show less

Berkeley, California

· Review, edit, and format new or revised test records, standard operating procedures, validations, drawings, batch records, and specifications submitted to QA under ISO 9001 quality management system· Upload, and route controlled documents for collaboration, approval, release, archival, and training in EDMS(Mastercontrol)· Train and assist end users on EDMS· Update and maintain QA logs and data bases· Assist with internal audits

· Schedule and prioritize incoming R&D, in-process, and finished product sample testing in order to meet 5 business day turnaround time· Sample analysis with analytical instruments and wet chemistry· Dilution and standardization of solutions· Data analysis of results against defined specifications to identify discrepancies, OOS(out of specification), NCMR( non-conforming material), and participate in quality investigations and CAPA (corrective actions preventive actions) if… Show more · Schedule and prioritize incoming R&D, in-process, and finished product sample testing in order to meet 5 business day turnaround time· Sample analysis with analytical instruments and wet chemistry· Dilution and standardization of solutions· Data analysis of results against defined specifications to identify discrepancies, OOS(out of specification), NCMR( non-conforming material), and participate in quality investigations and CAPA (corrective actions preventive actions) if needed· Operate and analyze data with Viscometer, Autotitrator, GC, and HPLC· Coordinate calibration and PM with vendors for QC equipment to stay compliant under ISO 9001 and 13485. · Instrument Training· GC/MS training seminar- Restek · GPC Training- Malvern Instruments· Practical course on viscosity measurement- Brookfield Engineering Labs, Inc Show less

· Sample analysis with analytical instruments and wet chemistry· Dilution and standardization of solutions· Data analysis of results against defined specifications to identify discrepancies, OOS(out of specification), NCMR( non-conforming material), and participate in quality investigations and CAPA (corrective actions preventive actions) if needed· Coordinate calibration and PM with vendors for QC equipment to stay compliant under ISO 9001 and 13485. · Operate and analyze data… Show more · Sample analysis with analytical instruments and wet chemistry· Dilution and standardization of solutions· Data analysis of results against defined specifications to identify discrepancies, OOS(out of specification), NCMR( non-conforming material), and participate in quality investigations and CAPA (corrective actions preventive actions) if needed· Coordinate calibration and PM with vendors for QC equipment to stay compliant under ISO 9001 and 13485. · Operate and analyze data with FTIR, Karl Kischer, pH meter, Viscometer and Auto titrator· Instrument Training:· GPC Training- Malvern Instruments· Practical course on viscosity measurement- Brookfield Engineering Labs, Inc Show less

· Sample analysis with analytical instruments and wet chemistry· Dilution and standardization of solutions· Data analysis of results against defined specifications to identify discrepancies, OOS(out of specification), NCMR( non-conforming material), and participate in quality investigations and CAPA (corrective actions preventive actions) if needed· Operate and analyze data with FTIR, Karl Fischer, Instron, and Melt Indexer

Alameda, Ca

Prepare reagents; sucrose, ethanol, acetic acid, 1xTBE to ensure a full stock when needed· Filtering, mixing, measuring, etc.· Inspect and approve materials in receiving

South San Francisco, Ca

· Responsible for disposal of defective materials · Assist production with dispensing of human plasma· Monitor daily touch plates from dilution and filling

Bachelors Of Science, Business Administration And Management

Bachelors, Business Administration : Management

Associates Of Science In Social And Behavioral Sciences

Associate Of Science - As, Administration Of Justice