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Medical Technologist and Quality assurance specialist

Location:
Fresno, Texas, United States
Salary:
100,000 to 110,000
Posted:
November 08, 2018

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Resume:

Application for Employment

Lauren Sayavedra

To whom it may concern

I am currently seeking employment and would like to apply for the following job title: QA Specialist IV.

The employment vacancy imparted the idea that the workplace is fast paced and innovative in it’s approach to laboratory testing. I am looking forward to working with a company that is able to evolve with the changing medical industry as well as stay competitive and become a leader in the forefront of emerging pharmaceutical technologies. I eagerly anticipate to gain further experience and knowledge in the pharmaceutical field as well as impart the knowledge I have with ISO 13485, 820,821 15189, so as to be of greater service for the company that I am employed with. I have 20 years of experience in the clinical laboratory science and quality regulatory field and have held supervisory and managerial positions. I am ASCP certified as a clinical laboratory scientist and continue to manage the certification as I am deeply involved with the laboratory production to make sure that the laboratory remains compliant. I have worked and trained in the areas of microbiology, immunology, serology, virology, cytogenetics, Viral Polymerase chain reaction testing, flow cytometry, clinical chemistry, blood bank medicine, applied chemistry, urinalysis, and hematology including hemostatic evaluation. I have a generalist training and am able to work competently in all the above mentioned sub fields including the quality assurance and regulatory component.

Thank you for your time in considering my application. For further questions please email me at ac7m4a@r.postjobfree.com (usually the best way to contact me) or call me at 210-***-****.

Resume:

LAUREN Y. SAYAVEDRA

The intent of this personal profile is to provide a detailed account of personal qualifications and achievements for prospective employment.

CALIFORNIA LICENSURE and ASCP LICENSURE:

Issued January 1, 2005. Clinical Laboratory Scientist licensure. License is current. ASCP Board Certified as a Clinical laboratory Scientist. License is current.

EMPLOYMENT

December 2015 to Current-Quality Management System’s lead Corporate Division -Neogenomics Inc location in Houston Texas

This position is directly responsible for the quality operations for the Houston Neogenomics site. The quality systems lead, under supervision of the Corporate Director of Quality, will partner with Pharma & Clinical Division functional leaders to ensure effective and appropriate operations and to drive a world-class quality culture with continuous improvement in systems, processes, mindsets, and behaviors. Vision & Strategy: The quality system’s lead provides oversight and leadership to the Pharma & Clinical Division laboratory operations ensuring adherence to and driving improvements to the Quality Management systems (QMS). Compliance: Ensures continual assessment of QMS data and on-going operations to ensure appropriate execution to company policies and procedures and regulatory requirements per CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820. Customer focus: Partner with external and internal customers to ensure resolution and communication of quality issues, data streams are provided, internalized and acted upon to ensure world-class quality performance. External Audits: Responsible for supporting the external and internal auditing activities and plans, and representing the quality operations to the auditor. Non-Conformance Management: Responsible for supporting the organization with root-cause analysis, corrective/preventive effectiveness checks verification and validation to execute complex CAPAs. Timely completion and follow up through to closure of CAPA actions. Provide the team with guidance on how to gather investigations within Non-Conformance Management System.

Process Improvement: The quality system’s lead partners with Pharma & Clinical Division functional leaders to identify key quality performance projects and implement systemic improvements and standards that will reduce customer complaints, non-conformances, compliance with Quality, business requirements, and improve quality performance. Actively participate and/or drives US/EU/Global QMS improvements as required. Quality Metrics: Measuring and monitoring of performance against agreed KPIs. Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities. Support reporting of key related metrics on quality risks, issues, initiatives, and projects at cross-functional meetings and shares new and or/revisions to regulatory requirements as defined by NeoGenomics Quality Management Director and the leadership team.

November 2010 to 2015 -Quality System’s supervisor-FISH department (2014-2015) and FISH Supervisor (2010-2014)

Neogenomics Inc is located in Irvine, California. It is a reference oncology testing laboratory with specialties in Molecular genetics, Cytogenetics, and Flourescent Insitu Hybridization

-The responsibility of the Quality system supervisor is to define, coordinate, and monitor quality assurance programs for the laboratory to ensure that quality procedures are followed and are up to date and compliant. The supervisor also plans and oversee’s internal inspections

-The responsibility of the FISH supervisor is to oversee the planning, coordination, evaluation and supervision of all technical and operational activities and staff members in the laboratory. The supervisor also coordinates R&D activities as they relate to the laboratory, develops a budget and manages department cost and resources that adhere to the budget.

July 2006 to November 2010 (Lead FISH technologist)

Clarient Inc. Clarient is a leader in cancer diagnostics, located in the heart of Aliso Viejo, California. It is a company that provides testing for local pathologists and oncologists to bring the standard of care back into their community. It is dedicated to providing clarity to complex problems by using a number of technologies such as Immunohistochemistry, Flow Cytometry, Flourescence In Situ Hybridization, Nucleic Acid and Molecular Genetics to help clients diagnose cancer cases. The company also provides them insight into what therapies will work best for these patients, and continue with follow-up and case monitoring in breast cancer, colorectal cancer, leukemias and lymphomas.

-The responsibility of the senior Clinical Laboratory Scientist in the FISH department is to perform laboratory tests and analysis according to established procedures in designated technical department on all FISH cases and Hematological FISH assay cases. They evaluate procedures and methods under direct supervision of more senior technologist, department supervisor, or group leader. Perform FISH microscopic analysis and image capture of cells to ensure timely completion of clinical cases. Prepares solutions and probes. Maintain laboratory records and perform general laboratory maintenance. Assists in training and orientation of trainees as required. Performs routine process of paraffin embedded cut tissue slides and cytogenetic prepared slides primarily performs routine analysis of cases. Possesses the ability to perform most aspects of case processing through to review as assigned. Performance of productivity and accuracy is expected to be at a level established by program goals for a CLS class II position.

January, 2006 to July 2006 (Senior Lead Clinical laboratory Scientist)

Senior Lead Clinical Laboratory Scientist at Oncotech Inc. Tustin, California

Oncotech is a dynamic and innovative cancer research facility in the heart of Tustin, California that currently is on the cutting edge of specific tumor type cancer chemotherapy treatment through in vitro diagnostic analysis.

-The responsibility of the lead clinical lab scientist is to grow tumor cell cultures by plating them on an agarose medium. The Clinical lab scientists also evaluates the Day Zero growth slides for any further hematological or microbiological abnormalities, and they are responsible for Gram Stain Quality control, assay plating Quality control, and cell linage Quality control, and the development and training of ancillary non-licensed and licensed employees.

December 20, 2004 to 2005 (Clinical laboratory Scientist)

Clinical laboratory Scientist 2 Coagulation Laboratory Quest Diagnostics San Juan Capistrano, California.

-The San Juan Capistrano Branch of Quest Diagnostics is located in Orange County in Southern California. The Coagulation laboratory performs many testing procedures which include screenings for autoimmune coagulation disorders, acquired coagulation disorders, and inherited coagulation disorders, and specialty testing for heparin monitoring.

-The Clinical laboratory scientist’s responsibilities in the Coagulation laboratory include performing esoteric coagulation screening and testing in specialty coagulation procedures which include, Lupus Anticoagulant Screening, Heparin Monitoring, Protein C screening and evaluation, Von willebrand disease differentiation, Ristocetin Cofactor screening and evaluation. The clinical laboratory scientists also performs Quality Control evaluations on all materials in the center, performs correlational studies on all designated testing procedures, evaluates and revises new and old methodologies, monitors positive and false positive testing in the various patient populations, observes shifts and trends in laboratory testing, manages Quality Control for designated procedures and manages reagent rental for those designated procedures, prepares designated testing for CAP inspections, state inspections, and internal inspections, reviews results from other technologists, trains new employees and reviews and evaluates training and reports all findings to the supervisor and laboratory manager.

October 2002 – November 2004 (Clinical laboratory Scientist-2002-2003 and Manager 2003-2004)

Medical Technologist ASCP Certified (Biomedical Scientist) Category II and Manager- Full-Time Position

Immunological and Viral Testing Center at Baptist Medical Center Downtown San Antonio, Texas USA.

- The Immunological and Viral testing center is located in downtown San Antonio, Texas it offers Hepatitis A, B, C testing, HIV I and II screening, syphilis screening, autoimmune diagnostic testing for all parts of San

Antonio, Bexar and Wilson counties.

-The Medical Technologist’s responsibilities include performing Hepatitis testing, HIV screening, syphilis screening, and autoimmune diagnostic testing. The Medical Technologist performs Quality Control evaluations on all materials in the center, performs correlational studies on autoimmune testing procedures, evaluates and revises new and old methodologies, monitors positive and false positive testing in the various patient populations, reports all findings to the Texas Department of Health and Human Services, and provides training to ancillary personnel, new students and staff.

- The Manager's responsibilities include scheduling, interviewing, quality control management of all areas, reagent rental management, preparation for a CAP inspection, reviewing results from other technologists, evaluating correlational trends and findings, revising old and new methodologies, monitoring Infectious disease trends before sending them out to the Department of Health and Human Services and the CDC, training new employees, doing evaluation summaries for new employees, and corrective action counseling for employees in the Microbiology, Hematology, Clinical Chemistry, and Immunology areas of the laboratory. The laboratory manager reports to the Director of the laboratory.

February 2002 - October 2002

Certified Clinical Nursing Assistant Part-Time (Feb. 2002 to May 2002) then Full-Time Position ( June 2002 to October 2002)

HealthSouth Rehabilitation Center of San Antonio in San Antonio, Texas USA

-This is a community based rehabilitation center that offers long term therapy for patients with spinal cord and/or other neurological related damage.

- The responsibilities of the clinical nursing assistant include transcribing physician orders for rehabilitation and physical therapy, assuring proper diagnostic testing is ordered, assuring proper delivery of medication to nurses for patient administration, hourly monitoring of assigned patients, (usually about ten), performing vital sign checks that included body temperature, respirations, pulse, blood pressure, monitor activities of daily living, monitor patients while they perform their assigned exercise regiments, monitor patients’ task orientation, and phlebotomy for diagnostic testing. The clinical nursing assistant also assists in the orientation and training of new employees.

May 2001- May 2002

Paid apprenticeship at University Hospital Full-Time

EMPLOYMENT CONTINUED

June 1999- July 2001

Certified Nursing Assistant Full-Time (June 1999 to April 2001)/ then Part-Time (May 2001 to July 2001)

North Central Baptist Hospital San Antonio, Texas USA

- A community based hospital that specializes in the treatment and care of cardiac and oncology patients.

- Responsibilities of the certified nursing assistant include monitoring patient vital signs, monitoring activities of daily living, ordering needed surgical and medical supplies for both the cardiac and oncology floors, arranging patient activity schedules, arranging patient social activities for patients with long term hospital stays, and ensuring precautionary isolation steps are taken by all other non-nursing staff and visitors when coming in contact with patients.

January 1999-April 1999

Apprenticeship at the University of Texas at San Antonio Full- Time

May 1993 - May 1999

Military Intelligence Officer in the United States of America Army Full-Time (May 1993 to January 1994) then Part-Time (Feb. 1994 to May 1999). (May 1999 to May 2003)Part-time. Psychological Interrogations Officer in Millitary Intelligence United States Army. Service in the Armed forces of the United States of America Based at Fort Sam Houston in San Antonio, Texas USA

-Responsibilities include organizing and participating in nationwide and international activities that include the use of classified instrumentation for the purpose of classified intelligence gathering. Additional responsibilities include the training of new soldiers in routine satellite communications and routine remote access unit communications, and other classified intelligence gathering communications.

EDUCATION

October 2003

National Certification in Clinical Laboratory Science as generalist Medical Technologist (Biomedical Scientist).

National Board of Registry American Society of Clinical Pathologists-membership is current.

May 2002

Bachelors of Science degree in Clinical Laboratory Sciences

Four year university degree from the University of Texas Allied Health Science Center School of Medicine in San Antonio, Texas. Concurrently, the degree encompassed two secondary majors in Biology and Clinical Psychology with a minor in Biochemistry.

June 2001

Phlebotomy certification

American Society of Clinical Pathologist. This was required course work for the Bachelors of Science degree in Clinical Laboratory Science-current.

September 1995

Clinical Nursing Assistant Certification

Board of Registry Texas Department of Health and Human Services

May 1994

Certification in Intelligence gathering -Remote Access Unit Operator and Satellite Systems Specialist Intelligence Officer-

United States of America-Army. Psychological Interrogations Officer United States Millitary Intelligence-Army.

ADDITIONAL PROFESSIONAL DEVELOPMENT

APPRENTICESHIPS

May 2001- May 2002

Cumulative Apprenticeships completed through University Hospital in San Antonio, Texas and through the University of Texas Allied Health Science Center School of Medicine in San Antonio, Texas USA

January 2002- May 2002 Clinical Chemistry Apprenticeship

The Medical Technologist is responsible for performing routine diagnostic blood chemistries and specialized protein electrophoresis studies for polyclonal, monoclonal, and hepatic malignancies. They are also responsible for the supervision of lower associate level medical technologists, ancillary staff, the training of new medical technologist and teaching new medical students about the diagnostic value of clinical chemistry results.

July 2001- December 2001 Hematology, Hemostatic Evaluation and Transfusion Medicine Apprenticeship

The Medical Technologist in Hematology is responsible for performing routine blood counts, Red Blood Cell and White Blood Cell microscopic examinations, aid the physicians in bone marrow extraction, preparation, slide counts, evaluation and interpretation of bone marrow results, performing routine hemostatic evaluation with the use of Prothrombin time Thrombin time and Activated Partial Thromboplastin time. Additional duties include performing platelet aggregation studies, and specialized workups for abnormal clotting factors. The Medical Technologist in Transfusion Medicine is responsible for Red Blood Cell, and component screening, antibody detection work ups, and the training of new students and ancillary staff.

May 2001 to July 2001 Infectious Disease Apprenticeships

The Medical technologist is responsible for performing routine cultures on all microbiology specimens to include all body fluids, tissues, secretions and fecal specimens. Additional responsibilities include Turberculosis identification and work ups, slide preparation and analysis, HIV screening, Hepatitis A, B, C screening, syphilis screening and confirmation testing, Rubella, Measles, Mumps, Varicella screening, Herpes, Epstein Barr screening, and infectious mononucleosis screening. The Medical Technologist is also responsible for interpretation of antibiotic susceptibility testing, and interpretation of all clinical results that are considered critical values. The Medical Technologist aids in the training of new medical students and ancillary staff.

January 1999-April 1999 Apprenticeship at the University of Texas at San Antonio

The clinical research associate’s responsibility include the evaluation of the Retroviral Transcriptase Polymerase Chain Reaction methodology and the DNA amplification methodology in the study of Growth associated protein -43 heat shock protein 70 and agrin messenger RNA and protein expression during the acquisition of hippocampus dependent spatial memory testing in rodents.

REFERENCE SECTION- Available upon request



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