Bunny M. Fisher, M.S., CLS, MLS(ASCP)H, SH CLS(NCA)

Clinical Laboratory Scientist

Quality Systems Regulatory Affairs Analyst Certified 1605 EAST 2ND STREET, #201

LONG BEACH, CALIFORNIA, 90802 UNITED STATES

408-***-**** acxuw2@r.postjobfree.com

December 11, 2016

Objective: Obtain a position in the role of a Project Manager, Quality Compliance POC Laboratory Supervisor, Clinical Laboratory Scientist Generalist (CA –LFS) H, SH, Quality Systems, Regulatory Affairs Analyst, and/or Medical Device professional. Dear Hiring Manager Professional,

I relocated from Silicon Valley last year and am excited about your opportunity. I was most recently employed as a full time as Quality Systems and Regulatory Affairs analyst for last two years at Spectra Laboratories in Milpitas, CA. In the last few months, I have been working as a Registry CLS Temp at Harbor UCLA and Salinas Valley Memorial Hospital. For the last 25+ years my role in laboratory medicine have been diverse and successful. I obtained a certification in Quality Systems Regulatory Affairs and Medical Devices certification. As a CLS Generalist/Supervisor and Lead Hematology Clinical Laboratory Scientist, I've worked in major medical centers (profit and non-profit), medical device manufacturing, research and development POLs as well as clinical trials. I have worked at national reference laboratories, Stanford HIV research, MLT and as an MLS educator. My experience as an adjunct professor at Diablo Valley College, De Anza Community College, and Highland Park Community College (Michigan) afforded me the opportunity to train young people looking to begin a healthcare career. As Manager of Education and Training at John Muir Hospital-MuirLab as a UCSF Clinical Affiliate, trained 25 CLSs and 4 MLTs. Highlights

● Lead CLS with expertise in performing and writing routine and special hematology procedures in medical center laboratories and QA.

● Management of Quality Systems: National Health Lab, Abbott, and Spectra Labs.

● Managed a department of 4-10 employees with a $98K budget.

● I’ve trained over 50 people to realize their dream of becoming laboratory professionals, passing their licenses and certifications.

● Passionate about providing quality care to patients and encouraging employees to make a positive difference to themselves, their patients and the organization. P.S. I am sincerely excited about working in your laboratory environment. I would like to schedule an interview to further discuss your opportunity and my qualifications, you may contact me anytime at 408-***-****. Thank you for spending time to review my cover letter. Sincerely,

Bunny M. Fisher

Bunny M. Fisher 408-***-**** acxuw2@r.postjobfree.com Page 2 of 4 Bunny M. Fisher, M.S., CLS, MLS(ASCP)H, SH CLS(NCA) Clinical Laboratory Scientist

Quality Systems Regulatory Affairs Certified

Resume’

Experienced California and ASCP licensed Clinical Laboratory Scientist (MS, CLS) Generalist with extensive knowledge of quality systems, project management, regulatory affairs, hospital clinical laboratories, medical device, reference laboratories, and academia. A well-rounded clinical hematology specialist with detailed skill sets in all aspects of hematopathology. Completed a one year Regulatory Affairs Certification at UCSC Extension covering all aspects of Quality Systems and Biomedical Regulatory Affairs processes. Extensive Clinical Management and Supervisory experience.

UCSC Regulatory Affairs and Medical

Device Certification, 6/2013

Perform internal and external

laboratory audits.

Well versed in GxP for Medical

Device / Clinical research, including

ISO15189, TJC, & CAP.

Ensure accuracy of clinical data

through validation studies.

Experienced in Proficiency Testing.

Maintain staff training and

competency records.

Professional conduct under pressure.

CA, CLS Generalist (Hematology,

Coagulation, UA, Body Fluids, Chem).

Experienced instrument calibration and

documentation of data; including repair,

replacement, and maintenance records.

Comprehensive experience in writing

and following clinical and diagnostic

procedures.

Conducts chemical and biologic

analysis of blood and body fluids,

including blood smear interpretation.

Ability to organize, interprets, and

analyze data to deliver on-time results.

Professional Experience

Harbor- UCLA 9/2016- Temp

Clinical Laboratory Scientist, Hematology Specialist (Generalist Salinas Valley Memorial Medical Center 8/2016- Temp Clinical Laboratory Scientist, Hematology Specialist (Generalist) Spectra Laboratories (Milpitas, CA) 2/2014 – 6/1/16 Quality Systems and Regulatory Affairs Specialist

Currently, a QS/RA Specialist for a large reference laboratory focusing on dialysis serving over 200,000 patients annually. Our business has 300 employees and we are accredited by ISO(15189), CAP, TJC, California and CLIA. We perform analysis on 30-50,000 patients per day for chem, immunochem, heme, and Environmental ICPMS. Perform internal and external audits. ValleyCare Medical Center 2012 - 2014

CLS Generalist

CLS Generalist for a 220 bed community hospital in Pleasanton, CA. Responsible for hematology, coagulation, chemistry, blood bank and basic microbiology (gram stain and PCR). Bunny M. Fisher 408-***-**** acxuw2@r.postjobfree.com Page 3 of 4 Diablo Valley College 2010 – 2012

Adjunct Professor, Hematology

Previously, a MLT program instructor for a two semester course in practical laboratory techniques and theoretical principles of clinical hematology, coagulation, body fluids, and urinalysis. John Muir Medical Center – MuirLab 2005 – 2011

Manager of Education and Training

MuirLab Community Outreach and CLS/MLT Student Selection

Managed and organized teams developing Bay Area Clinical Laboratory programs for Phlebotomy, CLS and MLTs for two hospitals and a new core lab with 700+ employees.

Perform blood group, type and compatibility testing as part of student training.

As part of a strategic Workforce plan, trained employees in preparation for a new core lab

(MuirLab) and at both hospitals. Developed MuirLab New Hire Orientation program.

Directly responsible for three education coordinators: Phlebotomy, Clinical Lab Science, LIS trainer with a department budget of $960,000.

Stanford Hospital and VA Palo Alto Medical Center 2003-2005 Associate Research Scientist

Participated in Stanford/VA HIV AIDS research teams consisting of M.D.s, post-doctoral and Stanford graduate students to develop a new ultra fluorescent in-situ hybridization technique with Flow Cytometry and RT- PCR. This technique detects drug resistant patients for development of targeted pharmacological therapies for HIV and HCV.

Perform HIV ultra-fluorescent in-situ hybridization two-color assay using a Coulter FC500.

Researched T-cell co-receptors CCR5 and CXCR4 cell receptors in HIV infection.

Presented research findings at Stanford Laboratory Symposium. Abbott Laboratories, Santa Clara, CA (ADD Hematology Business Unit) 1988 – 2003 Technical Product Development (TPD) Manager

As TPD Manager developed Quality Systems, CAPA and function as a Design Control Specialist, served on Abbott internal review boards and managed complaints to resolution with required CAPA documentation. Responsible for CD4000 product transfer from New Product Development to System Integration department to evaluate and resolve field service related issues from Quality and WWCMS. Abbott System Validation and Verification Manager

System IV&V department performed design validation and verification effort for the release of CD4000 software including T-Cell Panel Immuno Assay (CD 3/4/8). Performed design validations addressing customer and service issues.

Directly responsible for development of Hematology System Integration managing reference units and a department of seven MTs and two electronic technicians with a $1.2M budget.

Developed and implemented test plans, procedures, and reports for 510(k) Design History File.

Developed test procedures for compliance to ADD Design Control, ISO 9001, FDA, and UL.

Planned, organized, and implemented Stanford and UCSF Hematology clinical evaluations. Abbott Santa Clara Engineering R&D Medical Technologist

Performed hematology experiments using PWB and body fluids under the direction/supervision of Medical Directors, R&D Engineering Managers, and Scientists.

Directly responsible for the development of CD71 Reticulocyte method on the Cell Dyn 4000.

Automated test reporting by developing a test protocol Access database.

Responsible for verification of new hardware and software developed for Cell Dyn products. Bunny M. Fisher 408-***-**** acxuw2@r.postjobfree.com Page 4 of 4 Additional Professional Experience

Previous positions

Senior Medical Technologist, Supervisor National Health Laboratory (Lab Corp), Detroit, MI As a Medical Technologist in a large reference lab, progressed from a bench tech to Hematology supervisor and laboratory consultant. Managed successful integration of the Bayer H-6000

(CBC+DIFF). Trained personnel and Medical Technology trainees.

Senior Medical Technologist Detroit Medical Center (DMC, Harper/Grace Hospital), Detroit, MI Performed routine/special procedures in; hematology, coagulation, and bone marrow analysis. Responsibilities included operation, maintenance, training and troubleshooting of lab instrumentation i.e. Coulter, Bayer and Ortho systems.

Medical Laboratory Technician (MLT) Instructor Highland Park Community College, Detroit, MI Education

UCSC Certificate in Regulatory Affairs and Biomedical Science

MS Clinical Laboratory Science San Francisco State University, San Francisco CA

BS Medical Technology and Microbiology Eastern Michigan University, Ypsilanti MI Licenses and Certifications

American Society for Clinical Pathologists (ASCP): MLS 113120, H 001017, SH 001092

State of California Clinical Laboratory Science License: MTA 33368

National Credentialing Agency (NCA) 9321940

Professional Development

Regulatory Affairs Professional

CAP Inspection Team Leader Training

CAP Inspection Team Member Training

California Association of Medical Laboratory Technology (CAMLT), President Santa Clara County

(10 years)

American Society of Clinical Laboratory Science (ASCLS), association member

Notre Dame – Siemens Healthcare Diagnostics Executive Management Program

Contra Costa County Workforce Development Agency

Meeting Facilitation Program, Contra Costa Community College District

ASCLS, Integrating MLTs into the Workforce (presenter)

Global Quality Management Training

MAIC Six-Sigma, Biostatistics and QA/QC training

Toastmasters

Community (JDRF Diabetes Foundation and National Kidney Foundation)

2016 Los Angeles Heart Walk, Long Beach

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