SUZANE ISRAEL
Lake Forest,CA
Summary
Quality control professional experienced in developing an organization's quality strategy, procedures, and processes. Monitor quality performance from the supply chain and throughout the product development life cycle with a vast experience in Quality and Compliance for over 14+ years. Specializing in Quality Management Systems development, and implementation, improvements, and maintenance of the product Quality Design & Development, Production operation, In-market systems, and Post market Systems in compliance with FDA 21 CFR 820, ISO 13485 2016 & 14971 2019, CAP/CLIA/State requirements.
Develop and sustain Quality Management System in accordance with the applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed a culture of continuous improvement. Proven success in establishing and automating global quality programs (USA, Switzerland, & Singapore) such as Document Management and Corporate & Personnel Training & Competency Programs, Quality Events Programs (NCEs, Deviations, CAPAs), Change Control, Post Market Surveillance programs, Quality Metrics Data Review, and overall Quality Management Review Program process in support of Executive Leadership Review requirements.
Overview
15
15
years of professional experience
Work History
Quality Systems Manager
PRL, Pandemic Response Lab
Irvine, CA
07.2022 - 02.2023
- Improved Document Management program, Personnel Training & Competency program, and processes automation (eQMS) defined within Quality Management System Framework at Opentron's that governs all GxP-related activities, including CLIA, CAP, NYS, ISO 13485, and Good Documentation Practices
- Performed gap assessments to identify process deficiencies, provide reports to document detailed findings, recommend potential solutions, and collaborate with stakeholders to develop appropriate actions to resolve quality system issues
- Provided technical support and managed strategic initiatives and continuous improvement projects related to QMS (i.e., Design and Development, Validation, Change Control, and Automation Process Program)
- Investigated and resolved Quality System issues with cross-functional teams applying root cause analysis; trained and promoted continuous process improvement and operational excellence within organization
- Developed, managed, and onboarded requirements for new staff within Document Control and Training management systems
- Collaborated with cross-functional partners to develop appropriate training objectives, including specific GxP core training and training matrices for controlled document
- Managed companywide required annual GxP training, Human Resources, Safety, and cross-functional training program(s)
- As change agent, exemplify excellent change management skills to support optimized and ongoing/on-target training initiatives on time
- Lead and conducted internal company audits/inspections
- Maintained ownership of product roadmap and risk assessment strategy for electronic quality management system (eQMS), including supporting computer system validation (CSV) efforts
- Provided technical support and prepared documentation for product technical file submission documentation for FDA and NYSDOH
- Collaborated with Software Development in developing and managing State Report Requirements
- Established and managed state reports and business communications.
- Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines
- Worked with users to maintain accurate quality records and supporting materials to document quality-related activities
Senior Quality Specialist
GRAIL LLC
Menlo Park, US, UK
01.2021 - 05.2022
- Global process owner for Document Management, Training & Competency, Change Control, and Laboratory & Management Review metrics programs
- Designed and Development specific program requirements, Quality indicators, and Quality systems infrastructure implementation globally and fixed identified issues to improve workflows.
- Partnered with key stakeholders to capture all intricacies of different areas of products
- Established appropriate work flow for each change type in compliance with regulatory body
- Provided guidance and consultation to each change owner, change proposal, change risk & impact assessment reviews and led Change Control Committee meetings
- Interpreting compliance and regulatory requirements for incorporation into Quality Management Systems, governing policies, procedures, and documentation requirements
- Responsible for global training program, change control program, and hosting change control office hours for all global users
- Performed review, assessment, identification/review of risk and mitigation and oversees approval of each change record
- Ensure compliance with quality, regulatory, SOP, and other internal requirements
- Developed, Data output reports and reviewed and maintenance of Quality Metric Reports
- Drive NCR/DAR/CAPA and Audits/inspection program implementation, investigations & program effectiveness assessments within Manufacturing Science & Engineering (MSAT), Technology Transfer Operations, Lab operations, Automation Operations, and Equipment Engineering globally
- Drives global QMS continuous process improvements project initiatives to support business needs, business strategy, and product(s) regulatory strategy
- Prepared Design History File, Assay development and validation, and product software documentation for technical product file modular submission documentation for FDA PMA, NYSDOH, and Pharma Services customer technical file requirements
- Drive and execute electronic systems for Product in-house developed software, Quality Systems, Equipment Management, Environmental controls, Temperature & Humidity Monitoring, Procurement, customer complaints validation specification, and deliverables per FDA CFR Part 11 and Software Development Lifecycle program requirements (Artificial Intelligence software associated with Lab Operations, Veeva, MediaLabs, Blue Mountain, SalesForce, Trescal, NetSuite).
Supervisor
GRAIL LLC
Menlo Park, CA
01.2020 - 01.2021
- Developed and established maintenance and oversight of continuous improvements of GRAIL’s Corporate Document Management System
- Collaborated with key internal stakeholders and operational heads to ensure document control and training in accordance with internal policies and standard regulations
- Established and maintained effective cross-functional team communications to advance GRAIL’s quality activities and promote best practices
- Supported initiatives to simplify and integrate quality system requirements and business processes within document management and training program structure to facilitate global business growth
- Escalated areas of non-compliance, risk, and/or potential improvement to Management and develops plans for appropriate action to address causes of deficiencies
- Supported hiring, managing, developing, retaining, coaching, and mentoring staff, including setting individual and team goals and conducting performance reviews
- Supported inspection readiness plans during inspections on training-related matters
- Addressed, responded to, and completes CAPAs associated with document management needs and gaps and provide company training metrics for management reviews.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows
Quality Systems Leader
NeoGenomics Laboratories, Inc
Aliso Viejo, CA
10.2018 - 01.2020
- Led cross-functional teams to successfully complete Electronic Quality System Implementation projects
- Conducted quality assurance to verify accuracy of data used in implementation projects
- Communicated project updates to stakeholders at all levels
- Partnered with project team members to identify and quickly address problems and resolved staff conflicts and identified potential areas of improvement
- Wrote, updated and maintained project documentation
- Established and enforced project timelines and deadlines
- Assessed and analyzed customer requirements to develop effective project plans
- Updated customers and senior leaders on progress and roadblocks
- Monitored and tracked project progress to support timely completion
- Created and implemented contingency plans to address potential risks
- Developed and introduced IT strategies to improve operational efficiency
- Trained personnel on use of eQMS tools and applications
- Demonstrated leadership skills in managing projects from concept to completion
- Adaptable and proficient in learning new concepts quickly and efficiently
- Demonstrated creativity and resourcefulness through development of innovative solutions
Senior Quality Specialist
Nitto Avecia Pharma Services, Inc
Irvine, CA
04.2017 - 10.2018
- System Administrator for MasterControl, Electronic Document Management System and implemented improvement of Master Control Electronic, Document Management System
- Assisted in documentation, Internal and External audits to ensure regulatory and safety compliance with industry standard
- Backroom audit coordinator for external audits
- Troubleshoots user issues and provides user training and support
- Liaison with IT personnel on system issues
- Processed Change Control and Corrective Actions / Preventive Actions
- Facilitated and ensured that project milestones were met and documented.
- Fixed identified issues to increase productivity and boost workflows
- Educated employees on specific QA standards and confirmed maintenance of standards
Quality Sr. Specialist
Par Pharmaceutical
Irvine, CA
07.2008 - 03.2017
- Implemented MasterControl Electronic Document Management System and Compliance Wire Training Program
- System Administrator for Master Control, Compliance Wire, and TAS
- Conducted training for EDMs Programs and Training Coordinator for Quality Department
- Performed Validation activities for multiple eQMS; Document Management, Training Management, Enterprise Resource, and Planning Systems
- Troubleshoot end-user issues and serve as primary contact for Irvine employee site
- Created system reports providing metrics as a need in Quality Review Board meetings
- Managed issuance of Change control numbers, Lab notebooks, and Protocol numbers
- Developed and maintained roles and training materials in training matrix for Irvine site
- Supported Change Control System and issue numbers, identified proper reviewers and approvers, ensured all appropriate documentation was provided, and communicated change implementation date to responsible department
- Developed strong organizational and communication skills through coursework and volunteer activities
- Identified issues, analyzed information and provided solutions to problems
- Demonstrated leadership skills in managing projects from concept to completion
Education
Bachelor of Science - Applied Psychology
Biola University
Associate of Arts - Business Administration and Psychology
Saddleback Community College
Skills
Quality Management System Compliance
undefinedAccomplishments
- Strong competency and application of GxP (cGMP, GLP, GCP), 21 CFR Part 11, ISO 13485,
- CAP/CLIA, OSHA Safety, and comprehensive Quality Management system infrastructure and specific program requirements in a Clinical Laboratory, Medical Devices, Clinical
- Trials, and Drug Development in a highly regulated environment
- Strong knowledge and execution of product electronic systems assessment, System
- Quality and execution plan development, System validation specification, plan, and execution strategy implementation
- Proven ability to drive organizational Management of Change (MOC) and process-specific change Control (PSSCC)
- Proficient knowledge & application of Google Suite, Smartsheet, Microsoft Office Suite, and Data analytics tools
- Proven competency and ability to manage competing business priorities, strategy and program changes, decision-making flexibility, and agility in a fast-paced start-up business
- Ability to independently influence and drive team collaboration, decision-making, and alignment on project goals and timelines
- Fluent in English, Filipino (Tagalong and Visayan)
- Homeless Outreach
- Annual BBS Davao Ministry Fundraiser
- Lukeeta Foundation Running Water, Transportation, and Community Farming
- Suzane Israel Page 4 of 4
Timeline
Quality Systems Manager
PRL, Pandemic Response Lab
07.2022 - 02.2023
Senior Quality Specialist
GRAIL LLC
01.2021 - 05.2022
Supervisor
GRAIL LLC
01.2020 - 01.2021
Quality Systems Leader
NeoGenomics Laboratories, Inc
10.2018 - 01.2020
Senior Quality Specialist
Nitto Avecia Pharma Services, Inc
04.2017 - 10.2018
Quality Sr. Specialist
Par Pharmaceutical
07.2008 - 03.2017
Bachelor of Science - Applied Psychology
Biola University
Associate of Arts - Business Administration and Psychology
Saddleback Community College
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