Ruben Medina-Cestary, MS, MLS (ASCP)

Experience

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  Laboratorio Clinico y Patológico Dr. Noy

  Mar 2010 - Jan 2011

  Medical Technologist

  • Determined specimen acceptability and set up cultures in their corresponding media determined by the test ordered.• Performed Gram stains and set up cultures for bacterial identification and Antimicrobial Susceptibility Testing (AST) using bioMérieux’s VITEK system. • Processed Neisseria gonorrhoeae and Chlamydia trachomatis utilizing the APTIMA Gen-Probe and Tigris DTS System. • Performed quality control, maintenance, calibrations, standardizations and troubleshooting protocols to ensure proper functioning of instruments, reagents and procedures. • Processed, validated and reported specimen’s results following protocols and technical knowledge. • Followed established safety practices and participated in continuing education.• Worked effectively as part of a team to achieve department goals and objectives. • Hematology: Sysmex XS-1000i• Chemistry & Special Chemistry: Vitros 250, Elecsys 2010• Urinalysis: Clinitek 100 and Microscopic; Occult Blood (Hemosure)• Immunology & Serology: RPR, HIV, IM, Rubella, CRP, RF, Influenza A & B, βhCG Ql., Rapid Fetal Fibronectin• Phlebotomy Show less

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  Baylor Scott & White Health

  Mar 2011 - Oct 2015

   Assisted the supervisor in technical, quality, and administrative management of area of responsibility.  Micro. & Serology Lead Medical Tech./Weekend Lab. Supervisor Subject Matter Expert (SME) Lab. Rep. in the Baylor’s Microbiology Committee.  Helped organizing and distributing workload, overseeing technologists and review work area reports. Knowledge of CLIA regulations, readiness for CAP and The Joint Commission (TJC) inspections.  Ensured that TATs were met and maintained, while providing technical guidance and advice.  Helped with the development, evaluation, and implementation of new and revised procedures, as well as equipment and analyzers. Performed quality review of quality control reports. Performed duties such as ordering supplies, monitoring test volumes and creating work schedules. Oriented and trained new employees, pathology residents, pathology assistants and students. Provided data for cost analysis and budget preparation information.  Performed quality control, maintenance, calibrations, standardizations and troubleshooting protocols to ensure proper functioning of instruments, reagents, and procedures.  Processed, validated, and reported specimen’s results following protocols and technical knowledge.  Followed established safety practices and participated in continuing education. Worked effectively as part of a team to achieve department goals and objectives.  Core Lab. Experience:  Heme.: Sysmex XE 2100 (ESR & PFA) Coag.: Instrumentation Lab. ACL Top 500 (PT-INR, APTT, D-dimer, Fibrinogen, Heparin Assay and Thrombin Time) Chemistry & Special Chem.: Siemens Dimension Vista 1500, Abbott Architect i2000 SR (HIV 1/2 Ab/Ag screen, HBsAg, BNP, Cortisol and PTH) UA: Clinitek 500 (Serum/Urine Pregnancy test, Serum/Urine Osmolality, Fetal Fibronectin, Ionized Calcium and Magnesium) Micro.: Body fluids Gram stains, C. difficile screen, Group A Strep Rapid Test, Rapid Flu A/B and RSV Tests, and Occult blood. Show less • Performed quality control, maintenance, calibrations, standardizations and troubleshooting protocols to ensure proper functioning of instruments, reagents and procedures. • Processed, validated and reported specimen’s results following protocols and technical knowledge. • Followed established safety practices and participated in continuing education.• Worked effectively as part of a team to achieve department goals and objectives. • Hematology: Sysmex XE 5000 & SP-1000i• Chemistry & Special Chemistry: Siemens Dimension Vista 1500, Abbott Architect i2000 SR (HIV 1/2 Ab/Ag screen, HBsAg, BNP, Cortisol and PTH)• Urinalysis: Clinitek Atlas and UF-1000i• Microbiology: Body fluids Gram stains, C. difficile screen, Group A Strep Rapid Test, Rapid Influenza A/B and RSV Tests, Legionella and Streptococcus pneumoniae Urinary Antigen screen, Occult blood (stool and gastric fluid). Show less

  • Senior Medical Technologist

    Jul 2014 - Oct 2015

  • Medical Technologist/Night Shift Generalist

    Mar 2011 - Jul 2014
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  UT Southwestern Medical Center

  Feb 2012 - Jun 2012

  Medical Technologist/Core Lab. (PRN)

  • Chemistry & Immunochemistry: Roche Cobas 6000 analyzer series.• Performed quality control, maintenance, calibrations, standardizations and troubleshooting protocols to ensure proper functioning of instruments, reagents and procedures. • Processed, validated and reported specimen’s results following protocols and technical knowledge. • Followed established safety practices and participate of continuing education.• Worked effectively as part of a team to achieve department goals and objectives. Show less

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  Children's Health

  Jan 2014 - Nov 2014

  Medical Technologist/Microbiology, Virology and Molecular Lab. (PRN)

  • Determined specimen acceptability and set up cultures in their corresponding media determined by the test ordered.• Performed microbiological stains on body fluids (Gram stain, KOH/Calcofluor, Acridine Orange) and report findings. • Set up blood and body fluid cultures using the BacT/ALERT from bioMérieux.• Set up for bacterial identification using Bruker’s MALDI-TOF Biotyper and Antimicrobial Susceptibility Testing (AST) using Beckman Coulter’s MicroScan Walkaway system. • Processed respiratory panels using the FilmArray from Bio Fire Diagnostics.• Processed Clostridium difficile Tox B assays utilizing the GeneXpert by Cepheid. • Processed, validated and reported specimen’s results following protocols and technical knowledge. • Followed established safety practices and participate of continuing education.• Worked effectively as part of a team to achieve department goals and objectives. Show less

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  Mary Kay Global

  Oct 2015 - Oct 2021

  Analyst II, Product Stewardship

   Led the Product Governance and Compliance (PG&C) Committee and managed the product stewardship information across all R&D organizations, Procurement, Quality and regional partners.  Applied an advanced understanding of the discipline of Product Stewardship (e.g., raw materials/prohibited ingredients, product safety, product development/formulation guidelines, regulatory compliance, product end use and end of lifecycle). Analyzed the impact of emerging issues/supply chain changes as related to ingredients, formulas and other items marketed by Mary Kay Inc.  Facilitated ingredient and/or formula qualification process (e.g., toxicological data, regulatory compliance information such as impurities, COAs, fragrances/flavor allergens, etc.) by partnering across R&D, Procurement, regional organizations and suppliers, and informed on product development or supply chain risks.  Demonstrated independence when working on new ingredients/formulas with advanced complexity. Communicated clearly and prepared presentations on status, challenges and other needed information to R&D and Procurement partners. Proactively worked with external vendors. Consistently displayed critical thinking, recognized as an advanced technical contributor and executed sound technical judgement. Examples include completing ingredient survey reports, managing, and analyzing ingredient/formula information in company business systems, and/or preparing and problem-solving regulatory support documents for products (e.g., product information file or PIF). Responsible for planning and implementing continuous improvement initiatives to support overall department/R&D goals. Collaborated across R&D on projects and initiatives to accomplish team objectives. Certified/followed current Good Manufacturing Practices (cGMP) and supported Quality during internal audits and external regulatory agencies inspections.  Influenced the broader organization and demonstrated strong partnerships with others. Show less

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  Arbor Diagnostics

  Nov 2021 - Feb 2023

   Successfully managed the strategic operational planning of 5 laboratories: Clinical Pathology (Micro. & Molecular, and Core Lab.) and Anatomic Pathology (Cytology and Histology), and future testing pipelines.  Established and reinforced lab. performance metrics and corrective actions to achieve and sustain operational benchmarks that translated in quality patient care and customer service.  Direct management for organized and prioritized work, mentor to leaders, train and develop, and manage work performance.  Executed and implemented operational goals to organizational structure and ensured setup and understanding for success achieving them. Ensured adherence to CLIA and CAP requirements (e.g., inspection readiness, employee competencies, proficiency testing, etc.) and good lab. practices.  Identified and solved complex, cross-functional operational issues. Coordinated, led, mentored, and supported process improvements projects within functional roles to drive cost savings, efficiency, and productivity.  Drafted, edited, reviewed, and approved SOPs required for the performance of the analytical testing.  Ensured the diagnostic testing methodologies selected are validated and have the capability of providing accurate and precise results in compliance with regulatory agencies.  Collaborated and served as a resource to Sales, Marketing, IT, Process Improvement, Supply Chain, Customer Solutions/Client Services and executive teams to ensure alignment of product descriptions and compliance with regulatory requirements.  Served as a resource in the creation, validation, documentation, and approval of specimen pre-analytical, analytical and post-analytical results.  Ability to multitask and managed multiple competing priorities with successful follow-through and timely delivery. Strong interpersonal and teamwork skills; including the ability to easily convey concepts and priorities to peers, customers, and cross-functional teams. Show less  Coordinated and monitored the efficiency and effectiveness of the daily operations, budget reports and workload/workflows activities for the Micro. & Molecular Depart. Had 1 supervisor, 1 lead and 11 frontline for a total of 13 FTEs under my organizational structure. Translated operational goals into departmental goals to achieve KPIs. Demonstrated strong leadership, motivation, team building, communication, and advanced coaching skills that instill a strong sense of the company’s mission and vision in a team environment across all levels of organization. Responsible for recruitment, hiring, orientation, supervision, evaluation, disciplinary actions of departmental employees. Responsible for compliance with regulatory accreditation standards and inspection readiness. Responsible for quality control, monthly metrics, corrective actions, and root cause analysis. Reviewed and evaluated quality of reported test results, quality control and equipment maintenance procedures, proficiency testing and verifies appropriate documentation is maintained and corrective actions are implemented as necessary. Coordinated the development, evaluation/validation, or implementation of all new and current methodologies, procedures, reagents, systems, and instruments for use in the department in accordance with required regulatory and company standards. Participated in the establishment and implementation of the QA and continuous process improvement programs including quality monitors, incident reports, corrective actions, and documentation. Accomplishments: Achieved an 83% reduction of instrument consumables by streamlining QC. Successfully validated an extended stability for GBS cultures from 48 hours to 120 hours. A novel advantage over our competitors.  Successfully validated Strep B Carrot Broth, a new media that reduced TAT of positive GBS by 24 hours.  Consistently sustained a TAT of over 95%.  Improved the Women’s Health testing TAT from 36% to 80%. Show less

  • Director of Laboratory Operations

    Oct 2022 - Feb 2023

  • Microbiology & Molecular Manager

    Nov 2021 - Oct 2022
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  Mdxhealth

  Jul 2023 - now

  Director of Laboratory Operations

  Responsible for leading and driving an efficient, compliant, cost effective commercial laboratory operations and the management of the diagnostics laboratory, which includes inventory control, equipment management, annual budget management, capacity expectations, safety compliance, compliance to all applicable regulatory agency requirements. Exercise independent judgments and discretion, initiative, and resourcefulness in making recommendations about the workflow. Directing laboratory personnel, conducting, and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting lab results. Plan and direct assay transfer projects, facilitates IT system verification and validations testing, coordinating equipment and reagent transfers from Product Development. In charge of executing major multi-disciplinary optimization and validation projects. Show less