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Quality Control Training

Location:
Seattle, WA
Posted:
September 05, 2014

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Resume:

Highlights of Qualifications

. ** years of laboratory experience with progressive

leadership and advancement

. 6+ years of experience in a GLP/GCP/ GMP environment

. 3+ years of experience as a Technical Trainer in the

medical device industry

. Successful track record of achieving and exceeding

business objectives on a consistent basis

. Strong interpersonal and communication skills; verbal

and written

PROFESSIONAL EXPERIENCE

Atossa Genetics - NRLBH, Seattle, WA

Dec 2013 - Present

Laboratory Manager

. Manage personnel (6 Direct Reports)

. Evaluate and QC clinical specimens

. Chair Health and Safety Compliance Committee

. Achieve CAP accreditation, national licensure and CLIA

certification

. Develop and maintain cost analyses and laboratory budget

. Track laboratory matrices for QA/QC and implement

process improvement as needed

. Author non-clinical study protocols and reports

. Maintain tissue/cell culture

BD Diagnostics - TriPath, Burlington, NC

Jan 2013 - Nov 2013 Scientist III/Cytotechnologist - Contracted/Part-time

. Led quality control activities for reagent and

instrument manufacturing

. Performed functional and stability testing for

instrument and reagent manufacturing

. Consulted Core Teams and Project Managers ensuring key objectives were

properly aligned with the voice of customer and current laboratory

requirements

Aurora Diagnostics - GPA, Greensboro, NC

Nov 2012 - Nov 2013

Lead Cytotechnologist

May 2013 - Nov 2013

. Led quality control activities for cytopathology

laboratory

. Led process improvement activities for cytopathology

laboratory

. Reduced unsatisfactory rate of gynecological samples

Cytotechnologist

Nov 2012 - May 2013

. Evaluate and QC clinical cytology specimens

. Trained new and current personnel

. Operation, maintenance and repair of laboratory

equipment

Solstas Laboratory, Greensboro, NC

Jul 2007 - Nov 2012

Cytotechnologist - Part-Time

. Evaluated gynecological and non-gynecological cytology

specimens

BD Diagnostics - TriPath, Burlington, NC

Oct 2006 - Nov 2012

Scientist II/Cytotechnologist - Product Support

Jan 2010 - Nov 2012

. Traveled nationally and internationally to perform on-site complaint

investigations

. Led the design and development of quality control tools using image

analysis

. Led Corrective and Preventive Action (CAPA) investigations

. Maintained the design control process for new product development

. Led verification and validation activities

. Designed Measurement System Analyses

. Managed quality control release of all manufactured reagents

. Authored experimental study protocols and reports

. Performed clinical interpretation of histology, cytology,

Immunohistochemistry (IHC) and Immunocytochemistry (ICC) samples

Senior Instructor - Training and Education

Mar 2008 - Jan 2010

. Managed day-to-day operations of customer training

program

. Led technical training requirements for new product

development

. Managed field service training program

. Generated standard operating procedures

. Developed and executed training tools for clinical trial

sites

. Conducted on-site mid-trial reviews

. Performed on-site instrument installation and training

Education Resource Specialist - Training and Education

Oct 2006 - Mar 2008

. Identified sources to support external supply chain for

biological samples

. Developed and managed relationships with clients and

cross-functional teams

. Operation, maintenance and repair of laboratory

equipment

Laboratory Corporation of America, Burlington, NC

Apr 2006 -Oct 2006 Cytotechnologist

. Evaluated gynecological and non-gynecological specimens

Quest Diagnostics, Syosset, NY

Aug 2004 - Apr 2006 Cytotechnologist

. Evaluated gynecological and non-gynecological specimens

. Trained cytotechnology students and new hires

MEETING ABSTRACTS & PUBLICATIONS

1. Jelle W Kylstra, MD, MBA, Michael H Kalnoski, MD, Shu-Chih Chen, PhD,

Tawnie Vo, Gregory M La Rocco, Martin L Lee, PhD and Steven C Quay, MD,

PhD, FAC P (2014). "Proliferative Breast Disease identified by nipple

aspirate fluid cytopathology is common and has the laterality and

asymmetry characteristics of breast cancer" 1Atossa Genetics, Inc.,

Seattle, WA, United States, 98102 and 2UC LA School of Public Health, Los

Angeles, C A, United States.

2. R Marshall Austin, Barbara Benstein, Joel Bentz, Sandra Bigner, Gregory

G Freund, Gregory La Rocco, Ibrahim Ramzy, Lynnette Savaloja, Vinod B

Shidham (2009), "Market survey predictions on the future of US Pap

testing" Department of Pathology, Magee-Women's Hospital of University of

Pittsburgh Medical Center, 300 Halket Street, Pittsburgh, PA 15213, USA.

3. R Jain 1, M A Pedigo1, G La Rocco2 (2008) "Clinical Evaluation of ProEx

C on Liquid-based Cytology Specimens and its Correlation on P16INK4a and

HC2 High-Risk Human Papillomavirus (hrHPV) Testing" United States and

Canadian Academy of Pathology

4. "Molecular Markers in Cervical Cancer Screening, BD ProEx C", Asociacion

Mexicana de Tecnicos en Patobilogia A.C. (Mexican Association of

Technicians in Pathobiology), Mexican Congress, Tuxla Gutierrez, Chiapas,

November, 3rd 2007

5. Terri Stanford, Gregory La Rocco, Susan B. Stowell and Kumal K. Khurana

(2004), "Reprocessing of Unsatisfactory ThinPrep Pap Tests: Reduction in

Unsatisfactory ThinPrep Pap Tests and Detection of Cellular

Abnormalities" American Society of Cytopathology

6. Gregory La Rocco (2004), "Histiocytic Sarcoma of a Para-Spinal Mass"

American Society for Cytotechnology Annual Conference, Ashville, North

Carolina, April 2004

AWARDS/COMMENDATIONS

. BD Diagnostics - Women's Health and Cancer, Service Award - 2012

. BD Diagnostics - TriPath, Values Leadership Award - 2008

. Quest Diagnostics, Special Recognition for Outstanding Achievement -

2006

. American Society of Cytopathology, Cytotechnologist Scholarship - 2005

. SUNY Upstate Medical University, Outstanding Cytotechnology Student

Award - 2004

TECHNICAL SKILLS & TRAINING

ASCP Board Certified Cytotechnologist Validation Tool Kit Training

cGMP Certification Project Management Training

ThinPrep & SurePath LBC Certification MiniTab Statistical Software

IATA/DOT Certification MacroWorks 3 X-Keys

Molecular Diagnostics Certification MS Professional

Train the Trainer Certification MS Visio; MS Project

EDUCATION

Michigan State University, East Lansing, IL

Certificate of Completion in Molecular Laboratory Diagnostics, Aug 2009

Concentrations - Concepts in Molecular Biology; Clinical Applications of

Molecular Biology; Molecular Pathology; Immunology; Flow Cytometry;

Biomedical Laboratory Operations and Management

SUNY Upstate Medical University, Syracuse, NY

Bachelor of Science in Cytotechnology, Aug 2004



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