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Michelle Frese is listed as Sr. Manager, Quality Systems @ Prothena Biosciences, Inc. | Quality Management | Document Control | Compliance at Prothena Corporation, a company with 62 employees, based in San Francisco, California, United States. AeroLeads shows a matched LinkedIn profile for Michelle Frese.
Michelle Frese previously worked as Sr. Manager, Quality Systems at Prothena Corporation and Sr. Manager, Quality Systems at Sangamo Therapeutics, Inc.. Michelle Frese holds Bachelors Of Science, Business Administration And Management from City College Of San Francisco.
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As a Sr. Manager of Quality Systems, I oversee the implementation and global management of electronic quality management systems (EDMS, QMS, LMS), and QMS staff. I have extensive experience with managing all QMS programs such as CAPA, Nonconformance's, OOS, Change Controls, and Software Validations. I have 18 years of Quality experience in the biotechnology, life sciences and Medical Device industry, with extensive knowledge of ISO 9001, 13485, 27001, and GxP, cGMP, 21 CFR Part 11 standards and regulations.I am driven about developing, implementing, and managing quality management systems that ensure compliance, efficiency, and customer satisfaction. I have successfully led 13485 ISO certification for my previous company, as well as assisted with process validation, risk assessment, and supplier quality. I possess excellent leadership, communication, and problem-solving skills, and I effectively manage my team to meet company goals and mentor employee development.
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A career timeline built from the work history available for this profile.
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.
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.
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·.
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 ·.
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.
· 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(.
· 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·.
· 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·.
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
Other employees you can reach at prothena.com. View company contacts for 62 employees →
Monique Bautista-Martinez
Colleague at Prothena Corporation
Newark, New Jersey, United States, United States
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Leeann Louie
Colleague at Prothena Corporation
San Francisco Bay Area, United States
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Karen Ross
Colleague at Prothena Corporation
Los Angeles, California, United States, United States
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Lisa Matthews
Colleague at Prothena Corporation
Albuquerque, New Mexico, United States, United States
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Jose Tapia
Colleague at Prothena Corporation
Redwood City, California, United States, United States
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RK
Robert Kas-Shamoun Rn, Bsn
Colleague at Prothena Corporation
Detroit Metropolitan Area, United States
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Sarah Santos
Colleague at Prothena Corporation
New York City Metropolitan Area, United States
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AT
Angela Teliha
Colleague at Prothena Corporation
East Stroudsburg, Pennsylvania, United States, United States
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JB
Jenni Bursell
Colleague at Prothena Corporation
Greater Boston, United States
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AP
Amir Porat
Colleague at Prothena Corporation
South San Francisco, California, United States, United States
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Quick answers generated from the profile data available on this page.
Michelle Frese works for Prothena Corporation.
Michelle Frese is listed as Sr. Manager, Quality Systems @ Prothena Biosciences, Inc. | Quality Management | Document Control | Compliance at Prothena Corporation.
Michelle Frese is based in San Francisco, California, United States while working with Prothena Corporation.
Michelle Frese has worked for Prothena Corporation, Sangamo Therapeutics, Inc., Twist Bioscience, Dsm, and Berkeley Heartlab, Inc..
Michelle Frese's colleagues at Prothena Corporation include Monique Bautista-Martinez, Leeann Louie, Karen Ross, Lisa Matthews, and Jose Tapia.
You can use AeroLeads to view verified contact signals for Michelle Frese at Prothena Corporation, including work email, phone, and LinkedIn data when available.
Michelle Frese holds Bachelors Of Science, Business Administration And Management from City College Of San Francisco.
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