Lissette Montalvo
Boynton Beach,FL
Summary
Dynamic Quality Assurance Specialist with a proven track record at Moderna, enhancing quality systems and leading FDA remediation projects. Expert in technical writing and fluent in Spanish, I excel in teamwork and problem-solving, significantly improving process efficiency. Achieved over 40% reduction in manufacturing investigations, demonstrating exceptional detail orientation and integrity.
Overview
16
16
years of professional experience
Work History
Quality Assurance Specialist
Moderna
Remote
09.2021 - 12.2023
- Review of GMP Batch Records, COAs, BSE/TSE, Analytical Data, and translate review from Italian language
- Upload and maintain an archive of reviewed, approved, and executed records into Veeva QMS
- Transitioned documents into an upgraded QMS
- Begin KPI for review of Quality metrics
- Managed and lead investigations for Supply Chain
- Performed internal audits and prepared for internal readiness
Quality Engineer
Solgar-Nature’s Bounty
Leonia, NJ
07.2020 - 11.2020
- Administers all customer complaint investigations, inspects retained and standard samples, compares them with the complaint issue and GMP environment, and determines the root cause by consulting with technical services
- Reduced and closed out non-conformance investigations and deviations by meeting KPI goals
- Reduce CAPA’s for the Manufacturing, QC, and Technical Service Departments, and implement an effectiveness check
- Participated in the CVS audit inspection
- Lead a warehouse cycle count audit
- Performed Gemba walks of the production area to provide support for the continuous improvement needed
- Participate in Material Review Board meetings for the disposition of products
QA Validation Engineer/ QA Manager
Unipharma
Tamarac, FL
07.2019 - 07.2020
- Managed 5-10 people for the Quality Assurance department while managing projects for new product launches and meeting the timelines
- Approved protocols for new production and QC laboratory equipment (BFS, Tanks, HVAC system, & Temperature/ humidity monitoring system) & processes to produce products meeting internal and external purity, safety, data integrity and quality requirements for production of pharmaceuticals, dietary supplements, OTC’s and cosmetics
- Lead and hosted preparation for National Science Foundation (NSF) & UL audit and achieved certification and passing inspection
- Prepared for internal and external audits and responses
- Validation test data to determine whether systems or processes have met validation criteria, or to identify root causes of production issues
- Reviewed Validation Technical Transfer Packages
- Created, populated KPIs, and maintained databases for tracking deviations
- Final approver of Manufacturing Equipment and Instrument Validation including Installation Qualification, Operational Qualification, Performance Qualification reports including BFS (Blow Fill Seal technology) Validation and Computer systems (Vaisala, HVAC Agilent)
- Final approver of Validation Documentation following government regulations for (FDA, NSF, UL, and EMA) EUMA regulations 21 CFR Part 11 (Electronic Records and Electronic Signatures, Audit Trails and Security events) and company policies
- Assisted in Hazard Analysis/Component Design FMEA (Failure Mode Effective Analysis) program implementation
- Reviewed specifications/documents/Drawings, details of data collection and all the protocols of IQ/OQ/PQ and provide suggestions/solutions and work with subject matter experts as well as external resources (including suppliers, as needed)
- Implemented revised and improved corrective and preventive actions (CAPAs, CAR) and effectiveness check process
- Supported the Quality Unit in conducting and documenting process and system internal audits using cGMP, ISO and company requirements for observation response and corrective actions
- Final approver of Changes to Methods, Facilities, Equipment, and Processes
- Support Production Engineering, and project management in Product and Process and maintaining the quality management systems (QMS)
- Use best practices systems such as Total Quality Management, Good Manufacturing Practices, and Lean Manufacturing
- Project Managed and lead completion of remediation project in efforts to improve with FDA 483/ Warning Letter response
Engineering Consultant Manager Assistant
Medical Engineering Consultants
Fort Lauderdale, FL
10.2018 - 07.2019
- Managed 3 people and the development and improvement of the recruiting process including but not limited to work flows and metrics
- Managed Screening resumes, interviewed candidates and delivered employment offers as well as working with hiring managers to determine staffing needs for Pharmaceutical and Medical Device industry
- Developed advertising programs (internal and external) to ensure high visibility with potential candidates
- Communicated important employment information during delivery of employment offers (benefits, compensation, non- compete agreements)
Quality Assurance Manufacturing Engineer Lead
Actavis Laboratories/ Teva Pharmaceuticals
Davie, FL
11.2014 - 10.2018
- Managed and completed about 40% of Manufacturing and Facility investigations, technically writing complex investigation reports for the production department through problem solving and implementation of Corrective Actions, Preventative Maintenance and Root Cause Analysis
- Provided Assurance of Quality within of the process for the review and approval of Study Plans for equipment cleaning
- Reviewed Validation Protocols, Batch Records, Reduced Testing Protocols, Process Validation Protocols, Revision and Retired SOPs, Forms, and Equipment Change Controls
- Implemented and improved the Change Control System and Quality System to meet the company goals of compliance
- Met new generic pharmaceutical drug product pre-launch deadlines on review and approval of quality documentation for first to market company goals
- Ensured and improved the quality standard of the Quality Systems and manufacturing improvements
- Managed, planned and tracked the rebranding project for the Quality Control department for 200+ documents
- Certified White Belt in Operational Excellence and Kepnor Tregoe (KT) workshop trainings for Actavis
- Collaborate with Development, Regulatory Affairs, Metrology, and Maintenance for continuous GMP compliance and maintaining Quality Systems
Quality Assurance Specialist & Process Development Technician
ADMA (formally Biotest Pharmaceuticals)
Boca Raton, FL
10.2008 - 08.2014
- Quality Assurance Specialist: April 2012 – August 2014
- Performed QA inspections on Intermediates, and Final product shipping inspections and internal audits of Manufacturing and QC Laboratory to meet and ensure GMP compliance
- Development, scale-up, Biologics License Application (BLA) submission and FDA approval of Bivigam, a new product designed from plasma
- Managed and approved Cleaning Validation Project
- Created Certificates of Analysis, Certificates of Compliance, and Released Final Lot Dispositions for company products
- Managed the review of the Final Reports studies and Protocol executions from the Process Development Department for (BLA) submission
- Process Development Technician: July 2008 – April 2012
- Trained 5-10 employees of manufacturing in the process for production in the centrifuge process of cryo and plasma material
- Developed and executed Cleaning Validation Protocols for a GMP regulated FDA licensed product
- Technically wrote and executed final reports for manufacturing equipment
- Launched the Cleaning Validation Engineering for the Cleaning Validation campaign with completed success
- Executed robust, mixing, and buffer studies/ Design Verification for the process of the company for product optimization
- Implemented new process methods for making products at a small scale and evaluating existing processes to identify areas for improvement
- Executed the entire manufacturing process of plasma donor products in small scale through protein separation, fractionation, purification, centrifugation, ultrafiltration, chromatography, and nanofiltration
- Worked in sterile environments, filling product and environmental monitoring
- Improved yields of increasing plasma product from 10-15% while reducing costs by investigating alternative new machinery to improve efficiency for testing (alcohol testing instruments)
- Ordered suppliers of raw materials to resolve production problems related to raw materials that affected the manufacturing process
- Maintained laboratory equipment and inventory for laboratory supplies of the department
Lead Quality Control Chemist
Horizon Pharmaceuticals (Formerly Vital Pharma)
Riviera Beach, FL
07.2007 - 07.2008
- Managed QC testing to evaluate chemical ID testing and physical properties of various OTC’s such as eyewash, eye saline, and eye lubricants in a GMP regulated pharmaceutical sterile environment
- Performed sampling raw materials and component testing and release
- Performed Chemical Quality Control analysis of WFI, Raw Materials testing, QC Analysis for pH, Osmolality, Viscosity, HPLC, TOC, TIC, FT-IR, UV/VIS, Work in Process, and finished goods samples
- Performed spectrophotometer, particle air counter (RCS), chemical identification, potency assays, cross-trained in Microbiology work and troubled shoot instruments
- Data reporting and review, SOP generation and review, method and development, perform preventative maintenance on laboratory instruments, and troubleshoot instruments
Education
CMBA - Corporate Master of Business Administration
Florida International University
B.A. - Biological Science
Florida Atlantic University
Skills
- MS Microsoft
- MS Excel
- MS PowerPoint
- MS Outlook
- SAP
- EDMS
- Livelink
- TrackWise
- JDE
- LIMS
- Vaisala
- FDA remediation
- Technical writing
- Fluent in Spanish
- Teamwork
- Problem Solving
- Multi-tasking
- Quality Assurance
- Integrity
- Detail Oriented
Timeline
Quality Assurance Specialist
Moderna
09.2021 - 12.2023
Quality Engineer
Solgar-Nature’s Bounty
07.2020 - 11.2020
QA Validation Engineer/ QA Manager
Unipharma
07.2019 - 07.2020
Engineering Consultant Manager Assistant
Medical Engineering Consultants
10.2018 - 07.2019
Quality Assurance Manufacturing Engineer Lead
Actavis Laboratories/ Teva Pharmaceuticals
11.2014 - 10.2018
Quality Assurance Specialist & Process Development Technician
ADMA (formally Biotest Pharmaceuticals)
10.2008 - 08.2014
Lead Quality Control Chemist
Horizon Pharmaceuticals (Formerly Vital Pharma)
07.2007 - 07.2008
CMBA - Corporate Master of Business Administration
Florida International University
B.A. - Biological Science
Florida Atlantic University
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