Leidy Gonzalez
Round Rock,TX
Summary
Detail-oriented Quality Control Specialist with extensive experience in operations monitoring, quality control inspections, and comprehensive document review. Proven ability to apply critical reasoning and meticulous attention to detail to ensure compliance with industry standards and enhance product quality. Skilled in conducting thorough inspections and audits that drive continuous improvement and operational excellence. Committed to fostering a culture of quality and precision within the organization.
Overview
2027
2027
years of professional experience
Work History
Quality Assurance Technician
FSG Electric
Round Rock, TX
2024 - Current
- Conducted thorough inspections of products to ensure compliance with quality standards.
- Executed routine testing procedures using calibrated equipment to assess product performance.
- Documented findings and discrepancies, maintaining accurate records for quality assurance reporting.
- Collaborated with production teams to identify and resolve quality-related issues promptly.
- Assisted in the development and implementation of new testing protocols to enhance efficiency.
- Conducted root cause analyses for identified defects, implementing preventive measures to minimize recurrence rates.
- Contributed to continuous improvement initiatives by actively participating in regular team meetings and sharing insights about potential areas of improvement.
Quality Control Technician III
Tesla
Austin, TX
2022 - 01.2024
- Work closely with manufacturing, process, engineering, and quality teams to establish processes and procedures that will ensure consistently high quality
- Communicate emerging and trending quality issues and execute timely corrective action for quality mitigation and containment
- Audit manufacturing lines against released manufacturing processes and procedures
- Assist in the identification and resolution of manufacturing quality issues, contain parts or products as needed, and sort parts for quality requirements
- Monitor quality, determine the root cause of problems, and implement corrective actions and countermeasures
- Participate in continuous improvement activities, with manufacturing and external suppliers
- Analyze and disposition component and product defects as a member of the Material Review Board
- Anticipate potential problems and take preventative action.
Quality Control Associate
Luminex
Austin, TX
01.2020 - 01.2022
- Deliver timely and accurate Quality Control testing for bioassay and core consumable products
- Deliver timely and accurate completion of quality control and manufacturing process documentation including related business system transactions
- Generate Certificates of Quality Document and complete non-conformances Respond appropriately to environmental monitoring notifications of specialized storage areas; includes 24/7 call list rotation
- Execute stability study sample scheduling and processing
- Participate in program to sustain orderliness and cleanliness within related quality control and manufacturing area through routing sorting, labeling, systematic cleaning, and standardizing
- Assist in timely processing of purchased materials for release including related business system transactions
- Assist in on-time maintenance and calibration of Reagent QC measuring and monitoring devices Schedule timely outsource testing and services with associated documentation of results
- Assist in monitoring of departmental supplies and stocking of focused Reagent QC supplies; generate Purchase orders as needed
- Assist in filing retentions and retention maintenance program
- Prepare laboratory reagents for internal use
- Deliver timely and accurate completion of inventory cycle counts for select sub-inventories
- Participate in applicable departmental and interdepartmental training Maintain current training to standard operating procedures, quality control instructions (QCIs), and applicable changes affecting quality control
- Training of QC Technician and QC Associates to task-specific operations
- Assist in investigation and resolution of findings impacting Reagent Quality Control initiated through audits, non-conformances, corrective/preventive actions, or customer complaint escalation
- Assist in the execution of validations of test methods, equipment, and processes
- Assist in the review or revision of reagent QCIs, manufacturing instructions, and SOPs as required
- Support design transfer and the integration of new products and processes Support process development and process improvement projects
- Assist in compilation of technical deliverables as required
- Maintain effective and professional multi-level organizational interfaces Ensure personal compliance with Quality System
- Adhere to safety, disposal and gowning requirements applicable to department; facilitate departmental safety compliance
- Participate in additional quality activities as required.
Quality Control Technician
Luminex
Austin, TX
01.2020 - 01.2020
- Delivers on-time and accurate maintenance and calibration of departmental monitoring and measuring devices including associated documentation
- Schedules external maintenance and calibration of equipment
- Delivers timely and accurate processing of purchased materials for release including related business system transactions
- Provides routine business system reports for equipment calibration/maintenance and incoming quality control
- Documents non-conformances
- Performs timely filing of product retentions and maintains retention storage areas
- Participate in program to sustain orderliness and cleanliness within related quality control and manufacturing area through routing sorting, labeling, systematic cleaning, and standardizing
- Generates Purchase Orders as needed
- Perform timely and accurate sub-inventory cycle counts
- Perform filing/scanning of quality records
- Respond to environmental monitoring notifications of specialized storage areas; includes timely and appropriate responding with 24/7 call list rotation
- Assist with the sampling and testing of stability studies
- Assist in timely in-process and finished good testing
- Assist with timely and accurate completion of quality control and manufacturing process documentation including related business system transactions
- Assist in preparation of low complexity internal use reagents
- Participate in applicable departmental and interdepartmental training; maintain current training to standard operating procedures per matrix, QCIs and applicable changes affecting reagent quality control
- Ensure personal compliance with Quality System; facilitate sectional compliance with the Quality System
- Adhere to safety, disposal and gowning requirements applicable to department; facilitate departmental safety compliance
- Participate in additional quality activities as required
- Other duties as assigned.
Quality Assurance Technician
Luminex
Austin, TX
01.2019 - 01.2020
- Perform device history records (DHR) review for product release
- Complete any transaction oracle to release the Finished Goods products
- Create, update, approve and close non-conformance reports
Incoming Quality Inspector
Amgen
Juncos, PR
01.2016 - 01.2019
- Performed routine physical, visual, and dimensional inspections and testing on incoming components and materials in accordance with specifications and procedures. Supported quality assurance efforts by verifying that components adhered to required quality attributes set by the company and regulatory standards.
- Segregate and inspect retained samples according to the procedures
- Conduct document review, coordination, and compilation
- Cleanroom inspection and audit.
- Technical knowledge of ERP (SAP), LIMS, TrackWise and eBR (electronic batch record) systems
- Laboratory equipment use, calibration and maintenance
- Records data, observations and calculations in laboratory records and/or logbooks, as specified in the procedures
- Provide support to nonconformance investigations related to material issues
- Provide Support to Supplier Quality Management (SQM)
- Generate/compile quality data and reports
- Participate in internal regulatory audits
- Enter inspection results on SAP and EBR/MES.
Quality Assurance Technician
Johnson & Johnson, Medical Devices
San Lorenzo, PR
01.2014 - 01.2016
- Perform batch records review for product release
- Segregate and inspect Finished Goods and Retain Samples according to the company requirements
- Collaborated with quality operations leaders to execute additional responsibilities, such as collecting particle count data and conducting inspections on raw materials and processes. Facilitated internal audits and managed updates to non-conformance reports. Led efforts in identifying non-conformance defects and performed comprehensive in-process quality inspection tests.
- Achieved enhanced product quality through effective environmental audits in specific areas. Fostered adherence to good manufacturing practices and good documentation practices among associates, leading to improved operational standards.
Education
Bachelor of Science - Wildlife Management
University of Puerto Rico
Humacao, PRIndustrial Biotechnology - Biotechnology
University of Puerto RIco
Humacao, PR08-2016
Skills
- GMP/GDP
- Microsoft Office
- Laboratory equipment /techniques
- Measuring Equipment
- Oracle
- MES
- SAP
- LIMS
- TrackWise
Affiliations
ASQ
LANGUAGES
Spanish: Native language
English: C2 Proficient
Timeline
Quality Control Associate
Luminex
01.2020 - 01.2022
Quality Control Technician
Luminex
01.2020 - 01.2020
Quality Assurance Technician
Luminex
01.2019 - 01.2020
Incoming Quality Inspector
Amgen
01.2016 - 01.2019
Quality Assurance Technician
Johnson & Johnson, Medical Devices
01.2014 - 01.2016
Quality Assurance Technician
FSG Electric
2024 - Current
Quality Control Technician III
Tesla
2022 - 01.2024
Bachelor of Science - Wildlife Management
University of Puerto Rico
Industrial Biotechnology - Biotechnology
University of Puerto RIco