Marlyn Edesan
San Pablo,CA
Summary
Dynamic Quality Assurance professional with extensive experience in GMP and GxP principles. Proven track record in enhancing compliance and operational efficiency through effective quality issue identification and resolution. Skilled in SAP, Veeva Systems and fostering team collaboration to drive continuous improvement in manufacturing processes.
Overview
23
23
years of professional experience
Work History
Quality Assurance Associate II
Eteam Inc -Contract for Genentech, Inc.
South San Francisco, California
08.2025 - 05.2026
- Conduct routine QA walkthroughs on manufacturing floor, escalating quality events per SOPs and safety standards to ensure compliance.
- Review equipment logbooks, testing results, batch records and supporting documents for compliance and analysis purposes.
- Review environmental monitoring in controlled and aseptic manufacturing areas.
- Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
- Communicate quality issues with Drug Product Management promptly.
- Analyze quality and performance data to inform operational decision-making and enhance overall product quality.
- Perform quarantine and segregation of material in Drug Product (filling/inspection) manufacturing areas to minimize the risk of cross contamination.
- Perform standard inspection and random sampling inspection to quality standards.
- Approve Bill of Material and recipes in Basecamp and SAP.
- Identify and fix issues to increase productivity and boost workflows.
- Prepare reports and supporting documentation for audit findings.
- Facilitate deviation initiation and investigation activities to resolve quality issues and maintain regulatory compliance.
- Participate in Root Cause Analysis triage for Quality events.
- Support remediation and CAPA execution.
- Manage document control processes, including the review and approving SOPs and related quality documentation.
Quality Assurance Associate II
Magnit Global- Contract for Genentech, Inc.
South San Francisco, California
12.2023 - 08.2025
- Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
- Review equipment logs, testing results, batch records and supporting documents for compliance and analysis purposes.
- Review environmental monitoring in controlled and aseptic manufacturing areas.
- Communicate quality issues with Drug Product and Finished Goods Management promptly.
- Analyze quality and performance data to support operational decision-making.
- Quarantined and segregated material in drug product (filling/inspection) and final product (packaging) manufacturing areas to minimize risk of cross contamination.
- Perform standard inspection and random sampling inspection to quality standards.
- Identified and resolved issues to enhance productivity and streamline workflows.
- Prepared working papers, reports and supporting documentation for audit findings to facilitate compliance verification.
- Participate in Root Cause Analysis triage for Quality events.
- Assisted in completing remediation and CAPA execution.
Quality Assurance II Team Lead
Genentech, Inc.
South San Francisco, CA
04.2022 - 05.2023
- Established new and improved QA processes by developing test processes, test cases and assigning and executing tests.
- Developed and implemented metrics, utilizing industry best practices to enhance quality assurance processes.
- Directed daily quality assurance activities, fostering effective communication and coordination among team members.
- Acted as a key point of contact for all QA aspects of releases by providing QA services and coordinating QA resources internally and externally.
- Coached and motivated 5-person QA team to develop competencies.
- Performed internal audits to maintain operating procedure and regulatory standards compliance.
- Enforced compliance with federal, state, local and internal regulations related to product quality and operational activities.
- Created requirements for milestones and monitored completion of tasks for the QA team.
- Led process improvement initiatives with strategic planning and collaboration to enhance operational efficiency.
- Evaluated interactions between associates and customers to implement strategies for customer satisfaction improvement.
- Communicated directly with the QA team to resolve user-reported problems and questions.
- Supported development of materials, aids and curriculum to direct staff in procedures and operations.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Quality Assurance Associate II for Drug Product and Drug Substance
Genentech, Inc.
South San Francisco, CA
07.2003 - 05.2023
- Performed daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
- Reviewed and maintained documentation, including equipment logs and batch records, to ensure compliance and facilitate analysis.
- Reviewed environmental monitoring in controlled and aseptic manufacturing areas.
- Reviewed routine monitoring for water for injection (WFI), purified water (PW), and clean steam system.
- Executed quarantine, segregation, and line clearance activities in Drug Product filling and packaging areas to prevent cross contamination.
- Performed standard inspection of first pallet and random sampling inspection to quality standards.
- Inspected, verified and documented data of finished goods by company quality standards.
- Performed incoming material disposition by ensuring timely release of materials to avoid production delays. Evaluated damaged materials and determined acceptability.
- Analyzed quality and performance data to inform operational decision-making.
- Recorded findings of the inspection process, collaborating with the quality team to implement corrective actions.
- Communicated quality issues with Drug Substance and Drug Product Management promptly.
- Fixed identified issues to increase productivity and boost workflows.
- Performed deviation investigations, including product impact assessments as a result of deviation events related to facilities, utilities, and equipment.
- Ensured the appropriate CAPAs are initiated and coordinated with SMEs on required actions and subsequent closure.
- Completed deviation system and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Collaborated with Quality Change Control to develop, write, review and approve SOPs, specifications, batch documents, quality training and other documents for Drug Substance and Drug Product departments.
- Developed corrective action plans in conjunction with Drug Substance, Drug Product, Facilities, Validation, Production Engineer Managements to improve overall quality of Manufacturing process.
- Halted production line in case of major non-compliance of specifications, standards or quality discovered during the inspection process.
- Supported audit preparation through research, analysis and presentation development.
- Prepared working papers, reports and supporting documentation for audit findings.
- Maintained a neat, tidy work environment in Drug Substance and Drug Product manufacturing facilities.
Education
Continuing education - Finance
California State University - East Bay
Hayward, CASkills
- GMP and GxP knowledge
- Aseptic technique expertise
- Quality Issue Identification
- Drug Product Inspection
- Finished Goods Inspection
- Standards and Compliance
- ALCOA and data integrity
- LabWare LIMS/SingleLims
- Trackwise management system
- Veeva Vault Systems
- PharmaSuite
- Manufacturing execution system
- SAP
- Microsoft Windows and Office
- Google Applications
- Basecamp
Areas Of Strength And Expertise
- Knowledge of GMP, GCP, GxP Principles
- Knowledge of Aseptic Technique Procedures
- Drug Product Inspection
- Finished Goods Inspection
- Quality Issue Identification
- Standards and Compliance
- Knowledge of ALCOA & Data Integrity Principles
- LabWare LIMS/SingleLims
- SAP
- Manufacturing Execution System (MES)
- Discrepancy Management Systems - Trackwise
- Veeva Vault Systems
- PharmaSuite
- Basecamp
- Microsoft Windows and Office
- Google Applications
Timeline
Quality Assurance Associate II
Eteam Inc -Contract for Genentech, Inc.
08.2025 - 05.2026
Quality Assurance Associate II
Magnit Global- Contract for Genentech, Inc.
12.2023 - 08.2025
Quality Assurance II Team Lead
Genentech, Inc.
04.2022 - 05.2023
Quality Assurance Associate II for Drug Product and Drug Substance
Genentech, Inc.
07.2003 - 05.2023
Continuing education - Finance
California State University - East Bay