Katy Kubesh

Experience

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  ATS Labs

  Sept 2008 - Jan 2014

  Develops and carries out GMP/QSR Quality Assurance (QA) program, which enables the laboratory to meet desired quality standards at minimum cost. Monitors quality assurance activities of the laboratory to determine conformance with authorized policies and procedures and with sound practice. Makes appropriate recommendations for correction and improvement as may be necessary. Reviews and updates Quality Assurance procedures. Works with management on subcontractor approvals.Manages the daily quality assurance activities. Inspects and approves or rejects all incoming supplies. Evaluates and approves or rejects potential suppliers; maintains the approved supplier list. Reviews all documentation, including facility records and raw data generated by the Microbial Identification Laboratory and ensures errors are fully investigated. Reviews, approves and releases data and reports generated. Approves or rejects all laboratory supplies and test results. Show less

  • Senior Quality Assurance Specialist

    Jul 2013 - Jan 2014

  • Quality Assurance Auditor

    Aug 2009 - Jul 2013

  • Client Services Specialist

    Sept 2008 - Aug 2009
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  Accuratus Lab Services

  Dec 2013 - Jan 2017

  Responsible for managing the Quality and Regulatory Compliance program at Accuratus Lab Services. Recommends measures to ensure the fulfillment of the quality objectives of Executive Management and carries out the quality policies in the most efficient and economical manner. Manages the departmental budget. Recruits and trains new Quality Assurance personnel. Evaluates and implements operational improvements to enhance productivity and to ensure annual business and financial objectives are met. Seeks out and evaluates new ideas and current developments in the field of quality assurance and recommends means for their application wherever advisable. Manages the internal audit program. Hosts client and regulatory facility inspections/audits. Maintains effective relationships with other staff and departments to deliver high quality service to the organization and clients. Evaluates and manages 21 CFR Part 11 compliance of validated electronic systems. Show less Responsible for leading the Quality Assurance program at Accuratus Lab Services, Eagan MN facility and ensuring the quality level in all areas of the laboratory is maintained. Manages the daily quality assurance activities for the department and ensures efficient Quality Assurance operations. Performs Quality Assurance practices for Accuratus Lab Services. Evaluates/manages the performance of the Quality Assurance staff. Suggests and implements operational improvements to enhance productivity and to ensure annual objectives are met. Maintains effective relationships with other staff and departments to deliver high quality service to the organization. Seeks out and evaluates new ideas and current developments in the field of quality assurance and recommends means for their application wherever advisable. Assists in the Quality Assurance integration activities with other Accuratus Lab Services facilities. Coordinates internal department inspections and completes additional quality assurance projects.System Administrator for AccuraLIMS and Committee Chair Person for the Technology Utilization Committee at Accuratus Lab Services. Show less

  • Director of Quality Assurance

    Sept 2015 - Jan 2017

  • Quality Assurance Manager

    Mar 2015 - Sept 2015

  • Quality Assurance Supervisor

    Dec 2013 - Feb 2015
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  Analytical Lab Group

  Jan 2017 - Oct 2020

  Responsible for defining, communicating and implementing Analytical Lab Group’s quality objectives and vision. Carries out the Quality Policies in the most efficient and economical manner commensurate with ensuring continuing accuracy and precision of data produced. Builds and directs a team of QA professionals in the development and implementation of Quality Management Systems to ensure that the highest level of quality and compliance with the appropriate regulations is maintained at all Analytical Lab Group sites and promulgates a culture of excellence and compliance throughout the organization. Show less Responsible for the Quality Assurance program at Analytical Lab Group-Midwest and ensures that the quality level and compliance with the appropriate regulations is maintained in all areas of the laboratory. Proposes measures to ensure the fulfillment of the quality objectives of Analytical Lab Group. Carries out the Quality Policies in the most efficient and economical manner commensurate with ensuring continuing accuracy and precision of data produced. Manages the daily quality assurance activities for the department. Evaluates/manages the performance of the Quality Assurance staff. Develops and implements Analytical Lab Group’s Corporate Quality Management System and associated policies. Develops and implements corporate Quality Management System training programs. Works with QA personnel from all Analytical Lab Group sites to integrate the corporate Quality Management System into the site-specific quality management systems. Show less Responsible for the management, strategy and execution of IT infrastructure at Analytical Lab Group. Responsible for building and developing the IT function, processes, and procedures to support current and future business needs. Oversees technical projects in alignment with organizational goals. Directs the effective delivery of networks, development, and disaster recovery systems and processes. Works with information engineers to find solutions to manage business activities. Supervises a team of workers, while working closely with management, external vendors and advisers. Prepares financial budgets and presents proposals for capital projects to senior executives. Researches and recommends new products. Identifies new opportunities and leads efforts to improve IT processes. Show less

  • Director of Corporate Quality Assurance

    Jan 2020 - Oct 2020

  • Director of Quality Assurance

    May 2019 - Jan 2020

  • Director of Management Information Systems

    Jan 2017 - May 2019
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  Element Materials Technology

  Oct 2020 - now

  Developed and implemented strategies to integrate and optimize operational processes across different departments and functions. Identified and addressed operational bottlenecks to improve overall performance, while fostering collaboration and communication between teams to ensure alignment and coordination. Developed and implemented key performance indicators to measure operational effectiveness and identify opportunities for process improvement. Collaborated with leadership to develop and execute operational plans and strategies, oversaw the implementation of new systems and technologies, and ensured compliance with industry standards and regulations. Show less Successfully developed and implemented a comprehensive regulatory compliance strategy aligned with the Life Science division's strategic objectives. Ensured compliance with all relevant US and Canadian regulatory requirements, overseeing the development and maintenance of regulatory documentation. Through regular audits and inspections, identified areas for improvement and managed regulatory interactions with agencies. Provided regulatory guidance to cross-functional teams, stayed updated on regulatory changes, and implemented risk management strategies to mitigate risks. Fostered a culture of compliance and quality within the Life Sciences division. Show less

  • Director, Business Excellence

    Jan 2024 - now

  • Director, Operational Integration

    Jan 2023 - Dec 2023

  • Quality Director, Life Sciences

    Oct 2020 - Dec 2022