Lissette Montalvo Betances
Adma
Boynton Beach,FL
19
years of professional experience
Senior Quality Assurance and Quality Engineering professional with over 18 years of experience leading quality systems with continuous improvements, validation, regulatory compliance, FDA remediation within pharmaceutical, biologic's, sterile manufacturing, OTC, and dietary supplement industries. Proven success driving inspection audit readiness, leading cross-functional teams, managing complex quality system improvement needs and supporting successful FDA, NSF, UL, and internal audits. Skilled in root cause analysis, process optimization, and compliance with industry standards. Proven ability to collaborate effectively with teams, adapt to changing needs, and deliver impactful results. Known for reliability, problem-solving skills, and commitment to quality.
Work History
Quality Engineer Validation
5 Months- Implemented improvement to the Change Management Control, Change Review Board by reducing and consolidating changes for redundancy.
- Dedicated QEV to complex QC Change Controls, Protocol Validation review, approval and closure process.
- Facilitated and guided Metrology, Facilities, Validation, IT Equipment, Instruments and GMP impacted Software to improve clarity of rationale on quality documents.
- Led quality assurance initiatives to enhance product reliability and compliance with industry standards.
- Developed and implemented testing protocols to identify defects and improve manufacturing processes.
- Collaborated with cross-functional teams to resolve quality issues and streamline operations.
Quality Assurance Specialist
2 Years 3 Months- Reviewed GMP Batch Records, Certificate of Analysis (COAs), BSE/TSE, Analytical Data, and multilingual manufacturing records to ensure FDA compliance.
- Managed the review, approval, and archival of quality documents within Veeva QMS, improving document control and data integrity.
- Supported Successful transitioned of quality documents into an upgraded QMS.
- Developed KPI for review of Quality metrics to monitor quality performance and improve operational effectiveness.
- Managed and lead investigations for Supply Chain.
- Performed internal audits and prepared for internal readiness for regulatory and customer audits.
- Collaborated with cross-functional teams including Manufacturing, Supply Chain, Regulatory Affairs, and Quality Systems to strengthen compliance and improve quality performance.
Quality Engineer
4 Months- Led all customer complaint investigations, inspected retained and standard samples, compared them with the complaint issue and GMP environment, and utilizing Root Cause Analysis and CAPA methodologies to improve product quality and customer satisfaction.
- Reduced non-conformance deviation backlog by meeting KPI objectives.
- Supported successful in the CVS customer audits through inspection readiness activities.
- Lead a warehouse cycle count audits and to improve inventory accuracy.
- Performed routine Gemba walks of the production area to provide support for the continuous improvement and enhance GMP compliance.
- Led Material Review Board meetings for the disposition of products.
QA Validation Engineer/ QA Manager
1 Year- Managed up to 5 employees Quality Assurance team while overseeing validation projects supporting new product launches.
- Directed equipment and facility qualification activities for Blow-Fill-Seal (BFS) QC laboratory equipment, Tanks, HVAC system, & Environment monitoring systems &manufacturing equipments.
- Led and hosted preparation for National Science Foundation (NSF) & UL audit and achieved certification and successful inspections.
- Approved Validation Technical Transfer Packages.
- Established KPIs, and maintained dashboards for monitoring deviations, CAPAs, and quality system performance.
- 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, National Science Foundation -NSF, UL, and EMA) EUMA regulations 21 CFR Part 11
- Improved corrective and preventive actions (CAPAs, CAR) and effectiveness check processes, strengthening overall QMS performance.
- Supported Lean Manufacturing and Continuous Improvement initiatives that enhanced compliance and reduced operational risk.
- Led FDA remediation initiatives supporting to FDA 483 observations and Warning Letter commitments.
Engineering Consultant Manager Assistant
9 Months- 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
3 Years 11 Months- 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
5 Years 10 Months- 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 and laboratory supplies required for process development manufacturing process
Lead Quality Control Chemist
1 Year- 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
B.A. - Biological Science
Skills
Quality Management Systems (QMS)- Veeva QMS
Trackwise
EDMS
Livelink
SoftExpert
FDA
21 CFR Part 11
CGMP
Validation (IQ/OQ/PQ/PV)
Risk Management
Root Cause Analysis
MS Microsoft Office- Excel
PowerPoint
Outlook
SAP
Blue Mountain
JDE
LIMS. Vaisala
Continuous Improvement
Supplier Quality
Change Management/ Change Control
Deviation and CAPA Management
Audit Readiness
Teamwork- Cross-functional Leadership
Problem Solving
Detail Oriented
Accomplishments
Completed streamline of Lean Manufacturing White Belt for Activis and completed KPT program for Root Cause Analysis Training.
Languages
Spanish
Native or Bilingual
Timeline
Quality Engineer Validation
Adma
03.2026 - CurrentRead More
Quality Assurance Specialist
Moderna
09.2021 - 12.2023Read More
Quality Engineer
Solgar-Nature's Bounty
07.2020 - 11.2020Read More
QA Validation Engineer/ QA Manager
Unipharma
07.2019 - 07.2020Read More
Engineering Consultant Manager Assistant
Medical Engineering Consultants
10.2018 - 07.2019Read More
Quality Assurance Manufacturing Engineer Lead
Actavis Laboratories/ Teva Pharmaceuticals
11.2014 - 10.2018Read More
Quality Assurance Specialist & Process Development Technician
ADMA (formally Biotest Pharmaceuticals)
10.2008 - 08.2014Read More
Lead Quality Control Chemist
Horizon Pharmaceuticals (Formerly Vital Pharma)
07.2007 - 07.2008Read More
Florida International University
CMBA from Corporate Master of Business Administration
Read More
Florida Atlantic University
B.A. from Biological Science
Read More