Summary
Work History
Education
Skills
Affiliations
Languages
Timeline
Generic

L. González

Austin

Summary

Experienced Quality Control Specialist with abilities in blueprint interpretation, operations monitoring and quality control inspections. Outstanding communication, active listening and organizational talents. Applies excellent attention to detail and critical reasoning to successfully conduct inspection and Audits.



Work History

In-Process Quality Control Technician III 2023-24

Tesla
  • Deliver timely and accurate Quality Control testing for in-process material
  • Work closely with manufacturing, process, engineering, and quality teams to establish processes and procedures that will ensure consistently high quality
  • Comprehend current production quality trends based on dashboards or from occurrences in the line
  • Communicate emerging and trending quality issues and execute timely corrective action for quality mitigation and containment
  • Coach and train new associates
  • Maintain quality performance metrics and drive issues to root cause solutions
  • 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
  • Analyze and interpret data independently
  • Anticipate potential problems and take preventative action.

Incoming Quality Control Technician III 2022-23

Tesla
  • Deliver timely and accurate Quality Control testing for incoming material
  • Work closely with manufacturing, process, engineering, and quality teams to establish processes and procedures that will ensure consistently high quality
  • Comprehend current production quality trends based on dashboards or from occurrences in the line
  • Communicate emerging and trending quality issues and execute timely corrective action for quality mitigation and containment
  • Coach and train new associates
  • Maintain quality performance metrics and drive issues to root cause solutions
  • Audit manufacturing line against released manufacturing processes and procedures
  • Assist in the identification and resolution of manufacturing quality issues, contain parts or products as needed, 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
  • Analyze and interpret data independently
  • Anticipate potential problems and take preventative action.

Quality Control Associate I 2020-22

Luminex
  • 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 20-20

Luminex
  • 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
  • Performs departmental lab ware/glassware cleaning
  • Assists in waste management and chemical/biohazard disposal
  • 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 2019-20

Luminex
  • 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 when needed
  • Archiving manufacturing records per company’s procedure.

Incoming Quality Inspector 2016-19

Amgen
  • Conduct routine physical, visual, and dimensional inspection and/or testing to incoming components/material according to the specifications and procedures
  • Assign inspection profile based on history report and procedures
  • Segregate and inspect retained samples according to the procedures
  • Perform both sampling and inspection of primary and secondary components (vials, syringes, labels, etc.)
  • Ensure that primary components meet all the quality attributes required by the company and regulatory agencies
  • Assist with document review, coordination, and compilation
  • Room clearance inspection
  • Technical expert in the receipt, storage, dispensing, delivery, transfer, reconciliation, cycle counting, or shipment of materials per procedures and regulations
  • Technical knowledge of ERP (SAP), LIMS, TrackWise and eBR (electronic batch record) systems
  • Optimize the documentation process using MES (Werum) software
  • Laboratory equipment use, calibration and maintenance
  • Records data, observations and calculations in laboratory records and/or logbooks, as specified in the procedures
  • Use the appropriate personal protection equipment
  • 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
  • Data analysis and disposition of incoming components/ material
  • Classify defects/nonconformance
  • Enter inspection results on SAP and EBR/MES.

Quality Assurance Technician 2014-16

Johnson & Johnson (ETHICON LLC)
  • Perform batch records review for product release
  • Segregate and inspect Finished Goods and Retain Samples according to the company requirements
  • Complete any transaction in Manufacturing and Quality Systems to release the Finished Goods products
  • Perform other duties as required by Supervisor or Quality Operations Leader which include but are not limited to: collecting particle count data, QA Inspections (raw material, in process, etc.), internal Audits, update non-conformance reports, non-conformance defect identification and Classification, Perform in-process Quality Inspection tests, assist on Process and/or Equipment Validations, assist on non-conformance investigation, edit and verify non-conformance Rework Instructions, perform after rework inspections, monitoring conditions (ex
  • Environmental audit) required for a specific product or area and other activities that help ensure the quality of the product, ensure associates perform good manufacturing practices (GMPs) and Good Documentation Practice (GDP)
  • As part of my training period I received basic training in some computer programs like Mathlab and SAP.

Education

Bachelor of Science - Wildlife Management

University of Puerto Rico
Humacao, PR

Skills

  • GMP/GDP
  • Microsoft Office (Excel, Word PowerPoint, Outlook)
  • Laboratory equipment /techniques
  • Measuring Equipment
  • RI
  • Microsoft Office (Excel, Word PowerPoint, Outlook)
  • MES
  • SAP
  • LIMS
  • TrackWise
  • Oracle

Affiliations

  • ASQ

Languages

Spanish
Native language
English
Proficient
C2

Timeline

In-Process Quality Control Technician III 2023-24

Tesla

Incoming Quality Control Technician III 2022-23

Tesla

Quality Control Associate I 2020-22

Luminex

Quality Control Technician 20-20

Luminex

Quality Assurance Technician 2019-20

Luminex

Incoming Quality Inspector 2016-19

Amgen

Quality Assurance Technician 2014-16

Johnson & Johnson (ETHICON LLC)

Bachelor of Science - Wildlife Management

University of Puerto Rico

Similar Profiles

CREATE PROFILE
L. González