Paola Stefan
Hollywood,USA
Summary
With 8+ years of experience in engineering and manufacturing for the pharmaceutical and medical device industry. Expertise in the development and execution of validation protocols. Solid Technical Writing skills, knowledge of Good manufacturing practices (cGMP), Quality Management Systems for Medical Devices (ISO13485), and Good Documentation Practices (GDP). Ability to work in a team and provide a friendly atmosphere. Ability to listen to others and work with them. Knowledge on planning, time management and guidance to detail, as well high level of adaptability. Responsible, punctual, honest, open-minded and analytical, dynamic and high aspirations. Completely interested in fulfilling the different activities that are assigned. Working independently with problem-solving, judgment and decision-making skills. High learning ability.
Overview
9
9
years of professional experience
Work History
Quality Engineer II
Trividia Health
08.2022 - Current
- Spearhead the adherence to Quality System requirements, facilitate integration of new products and sustaining engineering efforts by executing deliverables essential for continuous improvement and corrective/preventive action initiatives
- Develop, strategize and execute Installation, Operational, and Performance Qualification Protocols, Validation Plans, as well as Variable and Attribute Test Method Validation Protocols, leveraging extensive experience to ensure robust validation processes
- Demonstrate commitment to regulatory compliance, ensuring seamless alignment with FDA and ISO guidelines, thereby safeguarding products' adherence to the highest quality standards
- Develop inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Manages Quality deliverables and design control related activities required for new product development & continuous improvement projects
- Serve as a key liaison with Research & Development/Process Development teams in the creation, review, approval, and maintenance of crafted design control documentation, reflecting a deep understanding of regulatory requirements and best practices
- Conduct Internal and Suppliers Quality Audits, applying seasoned judgment and insight to ensure thorough adherence to ISO 13485 requirements and facilitate continuous improvement efforts
- Provide strategic leadership in navigating the Risk Management process, offering expert input and guidance in alignment with ISO 14971 guidelines to mitigate risk effectively and ensure product safety and efficacy
- Demonstrate mastery in preparing and maintaining Design Control Requirements per 21 CFR 820, leveraging regulatory knowledge and experience to ensure compliance and excellence in documentation
- Apply seasoned judgment and expertise in performing comprehensive evaluation, testing, analysis, and recommendations on new or existing products, processes, materials, and improvements, driving continuous enhancement of product performance and customer satisfaction
- Foster a culture of continuous learning and professional growth by providing thorough training, comprehensive documentation, and dedicated support to the QA Engineering team
- Lead efforts to enhance process efficiency by taking charge of the development or enhancement of Quality System processes and procedures, utilizing extensive expertise to streamline operations and propel ongoing improvement endeavors
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Work with approved suppliers in product and/or process-related changes, updates and improvements
- Provide strategic oversight in consolidating updates to Risk Management files and presenting findings to teams and Management, drawing upon comprehensive experience to inform strategic decision-making
- Harness post-market review data to iteratively update Risk Management Files, demonstrating a proactive approach to ensuring ongoing product safety and efficacy
- Updates Risk Management File based on complaint trending from post market review
- Provide leadership and technical guidance to Quality & Regulatory Compliance and Manufacturing Operations staff, drawing upon extensive experience to drive excellence in manufacturing process controls
- Lead efforts to train QC inspectors on advanced inspection methodologies, leveraging deep expertise to ensure the highest standards of quality control across operations
- Led the development and implementation of detailed work instructions for various manufacturing processes, including assembly, inspection, and testing procedures
- Experience in overseeing injection molding processes, with knowledge in mold validation and injection molding techniques, operation and maintenance of auxiliary equipment essential to injection molding operations.
Quality Engineer
Trividia Health
05.2018 - 08.2022
- Developed and executed Installation, operational, and Performance Qualification Protocols and Validation Plans for Equipment pertaining New Packaging Production Meter Lines, Packaging Production Lines Changes, Strip Vial Packaging Lines, Laser Printers, Thermal-Transfer Printers, Color Sensors, COGNEX Inspection Cameras, Strip Carton UDI In-Line Verifier, Hand Scanners, Chart Recorders, Air Compressors
- Developed and executed Test Method Validation Protocols for Attribute and Variable testing pertaining to the inspection cameras and color sensors on Manufacturing and Packaging Strip Vial packaging lines and Glucose Meters packaging lines
- Reviewed and Redlined Manufacturing Work Instructions in order to comply with current GMP
- Coordinated Validation Executions and Status with the personnel involved in the Validation Process Plan
- Took participatory role in completing and maintaining Non Conformances
- Worked with minimum supervision, balanced multiple projects & prioritized work
- Drafted Engineering Reports pertaining to the execution of IQ, OQ, PQ, TMV’s, Process Characterizations
- Conducted and participated in Process Characterization studies, reviewed and summarize results in report
- Developed and reviewed pFMEAs and determined if updates were needed
- Assisted in Risk Management Plan Development, Preliminary Risk Analysis Development, uFMEA, Development, Risk Table Development, Overall Residual Risk Assessment, Risk Management Report Development
- Developed FTA to capture software related risks that may occur with CW to EDMS integration
- Developed and reviewed user needs for different types of Meters
Leasing Coordinator
ZRS Management
10.2017 - 04.2018
- Assisted management with qualifying all applications and signatories by verifying income, reviewing identification, and collection of all pertinent paperwork for approval
- Collected security deposit, application fee and rental monies
- Evaluated maintenance requests and assigned work orders accordingly for units
- Pre/post-occupancy apartment inspection
- Received deliveries and supported inventory operations
- Assisted residents with misc
- Inquiries and/or escalations
- Developed and maintained good customer service by assisting residents with misc
- Inquiries and/or escalations
- Updated resident records to ensure other tasks assigned by management and staff.
Validation Technician
UNIPHARMA LLC
11.2016 - 10.2017
- Assisted, developed and executed IQ/OQ/PQ validation protocols for utilities and facilities
- (HVAC systems, Reactors, Warehouse Mapping, Air Booths, Purified Water System)
- Drafted of deviations and Summary reports to close validations
- Developed Standard Operating Procedures for manufacturing and testing instrumentation
- Drafted Calibration Program
- Trained and supervised staff on procedures and manuals
- Prepared presentations on Power Point for staff training
- Performed monitoring and control of critical and non-critical instruments associated with all portable equipment and systems, under production (including sterile areas) and warehouse
- Performed monitoring and control of pressures, temperature and humidity in production and stability rooms
- Participated in sampling of conductivity, pH and chlorine using the right instruments
- Created charts in Excel for monitoring
- Participated in Site Acceptance Test of the Purified Water Generator and Distribution
- Elaborated equipment, areas and material drawings
- Participated in internal audits.
Quality Assurance Documentation Coordinator
UNIPHARMA LLC
08.2015 - 11.2016
- Administration of the controlled document system, equipment validation, equipment space distributions, procedures redaction, drawing elaboration
- Assisted on validation of equipment following Design, Installation, Operational and Performance qualification Protocols
- Performed Quality Assurance reviews of completed batch documentation for completion and accuracy
- Performed Monitoring and Control of Pest Control activities
- (Selecting the correct equipment for each manufacturing area)
- Controlled Quality Assurance documentation
- (Change Control, Controlled Copies)
- Managed distribution of new equipment in possible areas at Unipharma LLC facilities
- Developed Standard Operation and Procedures
- Coordinated and filed Quality Assurance training activities including training logs
- Reported and coordinated all Quality System activities
- Participated in internal audits.
Quality Assurance Assistant
Gavenplast de Venezuela S.A.
05.2015 - 07.2015
- Ensured safety, validation and control on each scheduled processes, maintenance and HSE, to ensure quality standards, high performance and process optimization
- Ensured correct safety equipment on every single worker at the plant
- Scheduled periodic maintenance to all the equipment used on the building process and the correct use of them
- Performed evaluation of Raw Materials
- Inspected the critical points of the process
- Released finished products
- Performed Manuals Updates
- Performed Product Traceability
- Validated building process following protocols established by the Master Engineer and report problems
- Ensured that workers are following instructions established.
Education
Bachelor of Science in Industrial Engineering (BSIE) -
Universidad Rafael Urdaneta
Maracaibo, Venezuela09.2015
Bachelor of High School Education: Bachelor of Science -
Mater Salvatoris School
Maracaibo, Venezuela07.2011
Skills
- Microsoft Office
- Minitab Statistical Software
- Proficient in ISO 9001, ISO 13485 and ISO 14971
- AutoCAD and Solidworks
References
Available upon request
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Greek
Elementary
Timeline
Quality Engineer II
Trividia Health
08.2022 - Current
Quality Engineer
Trividia Health
05.2018 - 08.2022
Leasing Coordinator
ZRS Management
10.2017 - 04.2018
Validation Technician
UNIPHARMA LLC
11.2016 - 10.2017
Quality Assurance Documentation Coordinator
UNIPHARMA LLC
08.2015 - 11.2016
Quality Assurance Assistant
Gavenplast de Venezuela S.A.
05.2015 - 07.2015
Bachelor of Science in Industrial Engineering (BSIE) -
Universidad Rafael Urdaneta
Bachelor of High School Education: Bachelor of Science -
Mater Salvatoris School
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