Jason Flores

Quality Assurance Manager at Quantum Materials Corp
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Location
San Marcos, Texas, United States, US

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Jerry Tischler

Extremely attentive to details and compliance is what I recall most when I think of Jason Flores. I had the pleasure of working with Jason for several months on a facility expansion project which included a requirement to generate and/or update multiple manufacturing, facility, equipment, and general QMS process documentation. Jason's ability to manage a multitude of actions and his team for this very critical and fast-paced project was very impressive. Jason (aka "J Flo" by his freinds), was always a positive team member no matter the situation and made it easier on the team when pressure was high. Jason will be an asset on any team and whatever company he works for.

Jazz Galaviz

I am extremely pleased to write this recommendation for Jason Flores. We worked together at Thermo Fisher Scientific with Jason as my supervisor. He is a conscientious and very hard working professional. He has an uncanny ability to dive into details as he came across many challenges. His reason for success against those challenges was his ability to chart out his own limitations. He is never afraid to ask for help and receive constructive criticism. As for his interpersonal style, He is a pleasant individual who believes in positive motivation and is dedicated and enthusiastic.

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Credentials

  • Six Sigma Green Belt (CSSGB)
    ASQ - World Headquarters
    Aug, 2023
    - Sep, 2024
  • Leading Management Systems Audit Teams ISO 19011:2018
    BSI
    Apr, 2023
    - Sep, 2024
  • Management Systems Auditing ISO 19011:2018
    BSI
    Apr, 2023
    - Sep, 2024
  • Medical Devices Quality Management Systems ISO 13485:2016
    BSI
    Apr, 2023
    - Sep, 2024
  • Kneat Academy Level One Power User
    Kneat Solutions
    Apr, 2022
    - Sep, 2024
  • European Union In-Vitro Diagnostic Device Regulation (IVDR) Auditor
    NSF International
    Oct, 2021
    - Sep, 2024
  • Certified Sterile Processing
    PDA - Parenteral Drug Association
    Aug, 2017
    - Sep, 2024

Experience

    • United States
    • Nanotechnology Research
    • 1 - 100 Employee
    • Quality Assurance Manager
      • Aug 2022 - Present

      Start-Up cGMP medical device facility for research and development of diagnostic devices utilizing nanomaterials. Responsible for development, implementation, and oversight of QMS. Accountable for incoming, manufacturing, and compliance quality. Review and approval of regulatory submissions, change control, deviations, CAPAs, commissioning/qualification/validation (CQV), standard operating procedures (SOPs), batch record production, protocols, etc. Regulatory inspections, customer and internal audits. Hire, train, motive, and inspire quality personnel. Develop, initiate, and maintain training program. Provide real time data analytics to support continuous improvement. Monitor critical KPIs and metrics to ensure compliance within QMS. Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Quality Assurance Supervisor
      • Sep 2021 - Aug 2022

      Start-Up cGMP biotechnology facility manufacturing Nucleic Acid Therapeutics (NATx). Implementation and oversight of the following: deviation management, batch record review, manufacturing quality, incoming quality, and compliance quality. Ensure appropriate tracking and timely resolution of quality issues (deviations, CAPAs, and change controls). Responsible for growth and leadership of quality engineers. Ensure timely review/approval of basic and technical documentation to include but not limited to, Commissioning/Qualification/Validations (CQV), standard operating procedures (SOPs), work instructions, batch production records, QC data review and approval. Provide support of regulatory inspections, customer and internal audits. Maintain visibility and investigate regulatory compliance requirements, guidelines, and trends. Ensure appropriate organization controls on in-process documentation. Site trainer for GMP compliance. Show less

    • Denmark
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Manufacturing Quality Assurance Supervisor
      • Mar 2020 - Sep 2021

      Start-Up cGMP pharmaceutical facility under a modified consent decree. Responsible for daily management of quality systems including but not limited to quality oversight of the manufacturing areas. Review and approval of work orders, protocols, qualifications, commissioning, validations, change controls. Assist with deviations including scope, impact, and associated corrective actions. Implementation and management of quality assurance processes, procedures, and best practices. Follow GDP (Good Distribution Practices) on all shipments and may be asked to be GDP representative for logistics. Responsible for personnel management including hiring, development, and performance management. Site trainer for compliance Good Documentation Practices (GDocP). Show less

    • Quality Engineer
      • Jul 2019 - Mar 2020

      Start-Up cGMP pharmaceutical facility under a modified consent decree. Provide oversight in manufacturing and packaging areas, incoming material inspection/approval, validation, deviations, commissioning and qualifications of facilities, equipment and processes, review and disposition of batch records and packaging records. Clearly communicate complex issues to management personnel. Ability to make independent decisions regarding quality related concerns or issues. Manage KPI's and metrics on a regular basis in order to meet release scheduling. Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing and environmental monitoring. Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs. Collect data for monthly and annual product review. Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during compounding, filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation. Show less

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Manufacturing Quality Supervisor
      • Dec 2017 - Jul 2019

      Monitor manufacturing processes and personnel to assure compliance with Standard Operation Procedures (SOPs) and cGMP compliance, persued resolution to issues as they arise with a quality risk assessment mindset on decision making, manage quality engineers and inspectors in a manufacturing environment. Hire, train, supervise, evaluate, and develop MQ employees, interfaced with operations, materials management, engineering, and other various departments to resolve issues and or determine if an exception report (ER/CAPA) is needed, conducted and prepared ER/QAR/CAPA investigation reports, manage projects to ensure completion within the required time schedule as required per quality systems, authored re-inspection plans and provided quality oversight during re-inspection to assure samples are within specification limits, partner with manufacturing to track and trend metrics and assist with continuous improvement, safety training to manufacturing and quality departments, effectively communicated in all directions as part of a leadership role. Show less

    • Events Services
    • 1 - 100 Employee
    • Manufacturing Quality Engineer
      • Jan 2016 - Dec 2017

      Provided quality oversight in manufacturing areas (dry/wet) for SOP and cGMP compliance, shift walkthrough specific person of accountability, reviewed batch records, completed FDA audited investigations using the DMIAC process, assisted with audits of internal/external processes, reviewed equipment/cleaning logbooks for impact to quality, performed data analysis to validate processes, edited/reviewed/revised SOPs, worked with cross functional teams to prevent/remediate deviations, completed safety inspections of processes/facilities/colleagues, monitored processes using SPC, M1 training (Pfizer lean manufacturing, yellow belt), trained Quality Engineers/colleagues/supervisors (QFE), coordinated projects, application development, PDA certified in sterilization processes, continuous improvement, special projects as the arise. Show less

    • United States
    • Motor Vehicle Manufacturing
    • 100 - 200 Employee
    • Quality Assurance Technician
      • Aug 2015 - Jan 2016

      Analyze Metrics (SPC, FMEA,8D, time studies, flow charts, value steam mapping, 5s),GD&T, perform root cause analysis, and recommend Corrective and Preventive Actions (CAPA’s), created and implemented layer audits to ensure compliance to SOP, capability analysis, maintenance of equipment, program Fanuc robotics systems, inspect shipping and receiving materials and product, MFI (Melt Flow Index) materials testing of product and material, training of quality team members, continuous improvement on manufacturing process to maximize quality though put while minimizing waste, lean manufacturing. Show less

    • United States
    • Higher Education
    • 700 & Above Employee
    • Project Intern
      • May 2014 - Jun 2015

      Undergraduate research with Dr. Tongdan Jin, “Overview on Electric Transportation and its Potentials in Industrial Demand Response”, Published paper on the research. Undergraduate research with Dr. Tongdan Jin, “Overview on Electric Transportation and its Potentials in Industrial Demand Response”, Published paper on the research.

Education

  • Texas State University
    Bachelor of Science - BS, Industrial Engineering

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