STEVEN Y. MARK

Boca Raton, Florida ***** 954-***-**** adtw29@r.postjobfree.com

PROFESSIONAL SUMMARY

An established, well-seasoned, formal military educated, Medical Laboratory Professional with 30+ years of combined career experiences within both the highly technical and regulated Medical Laboratory Testing environment, AP & Cytology and Precision Medical Instrumentation Manufacturing sector, functioning in supervisory, quality assurance, product management, technical support and educational program development and Instructor roles, each with significantly important regulatory required accreditation and licensing documentation responsibilities. Functioning in roles within two completely operational environment yet having similar documentation responsibilities has benefited me greatly throughout my career by having attained a completely different perspective in which to view any given situation from, while also serving to elevate my critical thinking skills and deepening my well of knowledge and practical skills from which to draw from to proficiently achieve any given targeted objective of a high complex nature and/or of unfamiliar subject matter. My people-centric nature has greatly contributed my building strong professional relationships essential in matters requiring cross function collaboration with internal and external sources. Given the opportunity I am confident that my broad and diverse base of knowledge base, well-honed practical skills and high degree of organized and systematic approach to achieving objectives, attention to detail persona, hyper-focused attention-to-detail, comprehensive knowledge and fluid use of medical and surgical terminology, comprehensive command and use of the English language and grammatical use, High-Degree and extensive proof reading with focus on the utilization of appropriate grammatical use and completeness literally meaning the dotting of every “I” and crossing of every “T”. In addition to the critical multi-diverse broad base of knowledge well-honed set of practical skills and broad knowledge base of multi-disciplinary medical knowledge stated above, I am confident that my consistent unwavering Analytic, Systematic and Organized approach not to only successfully achieve the goal at hand, but for many a reason to do so as accurately, concisely and professionally the first time which would not only contribute to being recognized as the “Gold” standard in any subject-specific matter but in doing so will directly serve to further streamline and reduce turn-around-time (TAT) which will have the direct impact of reducing unnecessary added stress and pressure on the staff by eliminating, or at the very least, significantly reducing the need to have to repeat or revisit areas of inaccuracies and/or ambiguity. However, I know from my extensive past experiences, this can be easily accomplished utilizing the power of the TEAM as a whole and will be met with appreciation, enhanced respect and trust which begins with the training and required use of a developed robust, no-nonsense on-boarding training of expectations, an accurately thorough competency assessment of each staff member, providing the tools needed to be successful through proactively providing tools via and proactively providing education, training and transparent robust competency assessment of each and every TEAM members strengths and identification of areas of improvement and the exact no more, no less expectations of responsibility, which I am more than capable of achieving and would welcome the responsibilities, if chosen to fulfil the responsibilities of this essential and critical responsibility. My confidence comes from 3o+ years of experience functioning in roles of significant responsibilities within both the exacting and tightly regulated Medical Laboratory Testing environment and the regimentation of expected consistency expected within the Precision Medical Instrumentation Manufacturing sector where I had the extremely fortunate opportunity to function for four (4) complete years as North American Product & Technical Support Manager. Given the opportunity to apply all or some of the knowledge and practical skills I possess and my belief a leader must lead by being in front and example which simply and effectively removes any doubt and strengthens the bonds paramount to maintaining Empowered, which naturally manifests itself by strengthened TEAM Unity, Strength, and Trust. I am s very loyal, tenacious, determined and will totally represent the organization in any positive way possible and welcome the opportunity to be the face of any organization providing me with the opportunity to directly contribute and always perpetuating forward the organizations reputation as being that of success, excellence, and commitment. success in as rapid but accurate and professionally accomplished manner. It should be noted my broad and well-diversified base of knowledge and multi-functional set of practical skills are not solely limited in application to one operational aspect but are wide ranging in scope and application.

SKILLS

QA Program Development Proficient

QA Program Assessment Proficient

QA Program Improvement Proficient

QA Monitoring (Passive & Direct)

Root Cause Analysis Investigation

Corrective Action Development

Inspection Ready Posture

Laboratory Instrumentation

Digital Image Transmission

Prognostic Image Analysis

Extensive Leadership Experience

Proactive TEAM Building

People-Centric Persona

Established Informational Resources

Professional Acumen Persona

Information Technology (IT) Literate

Pre-Implementation Validation Testing

Educated Decision-Making

Routine & Complex Technical Support

Measure Twice Cut Once Approach

Word Processing 70 /wpm (Typing)

Word / Excel / PowerPoint

CGMP / GCP / GLP / QSR / CmFGT

Regulatory Required Compliance

Regulatory & Clinical Affairs Handling

SOP Development / Production Skilled

Document Handling Proficient

Data Translation / Interpretation

Education Program Development

Engaging Interactive Oratory Style

Hyper-Focused Proof Reading

Medical / Technical Writing

Comprehensive Grammatical Use

Medical Terminology Fluency and Rhetorical Use

Effective Cross Function Collaboration

Multi-Discipline Medical Knowledge

Focused / Organized / Systematic

Intuitive / Inquisitive / Exacting

Ambitious / Self-Motivated / Tenacious

Work Smarter “Not” Harder Approach

Product Management Experienced

Pre-Analytic Specimen Handling

WORK HISTORY

REGIONAL QA COORDINATOR, AP / CYTOLOGY 02/2019 - 06/2021

Integrated Regional Laboratories, LLC

Fort Lauderdale, Florida

Primary Responsibilities included technical and operational oversight and investigation of reported or facility identified non-conforming events with my focus of responsibility being that of the Pathology and Cytology laboratories operating within the company, HCA, Inc., owned and operated 70+ medical center facilities located throughout the State of Florida in addition to the Pathology departments administrative functioning, Another role of responsibility was the initiation, facilitation and often times my direct participation in the investigation to identify the origin and cause of the noted deficiency, primarily for the purpose of either the revision of the current policy if any, or as collaborative decision the development and implementation of a new more corrective action plan.

If determined to rise to a regulatory body determined level of patient harm immediate an immediate full scale documented Root Cause Analysis (RCA) investigation was performed, with my responsibility being directly facilitating the proper performance of the RCA investigation, often ending up requiring my direct participation

Other primary roles included the direct responsibility for the proper document preparation and handling as required by any give related subject matter, the development of the materials and visual aids and my presentation of technical and procedural related information for continuing education purpose and competency assessment programs in support of maintaining staff competency and consistency of a high-level of technical performance and the subsequent quality of testing results.

Drafted reports on quality verification activity outcomes, presenting findings to decision-makers and recommending response efforts.

Investigated recurring customer complaints, determining source of the mishandling, mislabeling or lost specimen non-conformance incidences and recommending solutions.

Addressed non-conformance events (NCE), at times requiring the need to pausing production to first identify the origin and cause of the event then if necessary to implement new more stringent corrective action measures. or correcting and/or reinforcing the existing measures.

Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.

Assisted with quality control audits and semi-annual full "mock" inspections of every laboratory department.

Produced periodic data and statistical reports for quality improvement purposes

Developed educational materials used to train staff on issues of technical performance, Quality Assurance as well as for Proactive continuing education purposes.

Recorded findings of inspection process, collaborating with quality team to implement corrective actions.

EAST FLORIDA DIVISION QA COORDINATOR, CLINICAL 03/2020 - 06/2021

Integrated Regional Laboratories, LLC

Fort Lauderdale, Florida

Facilitating formal cause and origin investigation with facility specific clinical laboratory administration of Non-Conforming Events (NCE) at any of the Medical Laboratory facilities assigned to and functioning within the designated East Florida Division. designated Medical Laboratory facilities reported technical performance and result discrepancies, operational processes, lost and/or compromised patient specimens, missed tests, etc. All constituting Non-Conforming Events (NCE)

Drafted reports on quality verification activity outcomes, presenting findings to decision-makers and recommending response efforts.

Addressed non-conformance issues, pausing production to correct errors.

Assisted with quality control audits.

Production of monthly, quarterly, and annual task specific and staff performance proficiency for quality improvement revision or redevelopment.

QC COORDINATOR, AP / CYTOLOGY 11/2012 - 2/2019

IMAGE ANALYSIS & EDUCATION ADMINISTRATOR

Integrated Regional Laboratories, LLC

Fort Lauderdale, Florida

My responsibilities in my role as Quality Control Manager of the Histology and Cytology laboratories was multi-purpose in both scope and performance capacities, with my primary responsibility focusing on staff technical proficiency and quality of testing results, adherence to task specific performance standards gained by detailed specific documentation of performance assessment gained via visual observation and direct interaction

In support of daily quality control objectives, I was tasked with, and solely responsible for the daily microscopic review of a set percentage of randomly chosen completed patient specimen testing results for quality approval prior to distribution with detail specific findings and pertinent data documented

Additional tasks involved the development of staff technical competency assessment materials, visual and documented in form and the full participation in the standardization and documentation revision of common testing procedures and protocols across the organizations three regionally located core testing laboratory facilities throughout the State of Florida

Facilitation of and participation in the review, revision and development of new laboratory policies and procedure documentation in accordance with the respective licensing and accreditation governing bodies (i.e., JCAHO, CAP, CLIA, NCCLS, DOH, OSHA).

Addressed non-conformance issues, pausing production to correct errors.

Recorded findings of inspection process, collaborating with quality team to implement corrective actions.

Developed educational materials used to train staff on QA standards.

Collaborated with management to provide training on improved processes,

PATHOLOGY LABORATORY MANAGER 07/2005 - 11/2012

University Hospital & Medical Center

Tamarac, Florida

Responsibilities encompassed assisting with tissue specimen gross dissection, dictation, transcription, and preparation of tissue biopsies, surgical resections & non-gyn cytology specimens, performing frozen sectioning on fresh tissue samples when requested, assisting the surgeon at patient bedside in the collection of Thyroid FNA samples and its subsequent diagnostic preparation for immediate microscopic diagnostic interpretation by the Pathologist.

The performance of all transcription functions and the completion of outsourced special procedure requests and their transportation were also my responsibilities

Additional responsibilities included the review, revision and development of new laboratory policies and procedure documentation in accordance with the respective licensing and accreditation governing bodies (i.e., JCAHO, CAP, CLIA, NCCLS, DOH, OSHA).

Kept equipment maintained, facility clean and organized and inventory stocked to maximize performance.

Kept laboratory in compliance with applicable guidelines and laws.

Managed operational documents and produced reports detailing activities.

Supervised site investigations reported issues and escalated those that required further assistance.

Performed gross dissection of non-resected specimens under the direct supervision of Medical Laboratory Director.

Responsible for and performed all transcription functions to include t typing the dictated specimen gross description, final diagnostic findings dictated by the Pathologist and any other related specimen information diagnostic or prognostic in nature. If submitted out for specialized testing, which once received back the report information entered as an addendum making it part of the patient’s entire report. When requested I also performed Frozen Sectioning of fresh tissue and assisted the surgeon and Pathologist with performing then diagnostically preparing the specimen to be microscopically reviewed. other relevant special procedures performed, i.e., Frozen Sections & FNA's.

Managed overstocking, restocking and inventory control procedures for all shifts.

Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.

PATHOLOGY LABORATORY MANAGER 09/2001 - 12/2003

HISTOLOGY EDUCATION INSTRUCTOR

Palm Beach Pathology, P.A

West Palm Beach, Florida

Primary responsibilities consisted of the technical and operational oversight of Histology and Cytology laboratory functions and staff performance

Additional responsibilities included the review, revision and development of new laboratory policies and procedure documentation in accordance with the respective licensing and accreditation governing bodies (i.e., JCAHO, CAP, CLIA, NCCLS, DOH, OSHA).

Provided professional, educational and counsel to facilitate positive outcomes.

Interviewed, hired, and trained lab technicians to perform experiments and analyze results.

Set and oversaw quality assurance guidelines for laboratory work.

Played essential role in delivering individualized services and supporting instruction.

Kept laboratory in compliance with applicable guidelines and laws.

PATHOLOGY LABORATORY MANAGER 03/2000- 08/2001

EDUCATION ADMINISTRATOR & INSTRUCTOR

Dianon Systems, Inc.

Stratford, CT

Primary responsibilities encompassed the overall technical direction and administrative support relative to Histology laboratory operations and technical performance

Administrative duties included but were not limited to employee evaluations and development, competency testing, continuing education, departmental budgeting and capital equipment forecasts and expenditures

Additional responsibilities included the review, revision and development of new laboratory policies and procedure documentation in accordance with the respective licensing and accreditation governing bodies (i.e., JCAHO, CAP, CLIA, NCCLS, DOH, OSHA)

In conjunction with accreditation body Hartford School of Histotechnology the organizational goal of implementing an on campus “School of Histotechnology” was realized and was done for the purpose of providing those less fortunate an opportunity to progress without having to pay tuition but also as an incentive as a certain level of performance was required as one of the main deciding factors to be chosen. was achieved, and for which I served as educational proctor and instructor. It was a successful endeavor during the time I was there.

Set and oversaw quality assurance guidelines for laboratory work.

Interviewed, hired, and trained lab technicians to perform experiments and

Managed operational documents and produced reports detailing activities.

Kept laboratory in compliance with applicable guidelines and laws.

Supervised staff of 80 personnel on 3 shifts by implementing company policies, protocols, work rules and disciplinary action.

Managed overstocking, restocking and inventory control procedures during day shift.

Defined clear targets and objectives and communicated to other team members.

Maintained professional demeanor by staying calm when addressing unhappy or angry customers.

Evaluated employee performance and conveyed constructive feedback to improve skills

PRODUCT & TECHNICAL SUPPORT MANAGER 11/1995 -11/1999

Carl Zeiss, Inc. / Microm USA

Thornwood, NY

Utilizing a complete knowledge of the operational parameters and specific means of function of all product line instrumentation, their specific application of use and functioning methodology capabilities and pa all understanding of all responsible product of all responsible instrumentation parameters having a complete utilizing a acquiring and having complete knowledge and expertise in their practical application of Histology Instrumentation, Clinical Microscopes, utilized in and accessories and application expertise, to provide thorough in-depth product and applications support to both end users and sales staff via hands-on practical workshops, and when required slide show presentations and product specific literature. Additional responsibilities included participation in new instrument design and development, product testing, investigating and detailed documentation of performance issues and the production of technical reports, product bulletins and newsletters.

Distinguished product issues and gathered information on customer experiences.

Hosted product demonstrations and promoted features to clients.

Maintained internal product knowledge database.

Brainstormed with peers and other members of design team to determine enhancements and product features.

Traveled to manufacturing facilities to evaluate product creation and point out potential issues. Suggested enhancements to product design that would improve user experience.

EDUCATION

Associate of Science Degree

Medical Laboratory Technology 02/1985

Community College of The Air Force

Maxwell Air Force Base

Montgomery, AL

USAF Certificate of Training (Phase II)

Histotechnology / Cytology / Immunohistochemstry 12/1984

Tri-Service School of Histotechnology

Armed Forces Institute of Pathology

Washington, D.C

USAF Certificate of Training (Phase I)

Medical Laboratory Technology 06/1983

USAF School of Healthcare Sciences

Sheppard Air Force Base

Wichita Falls, TX

High School Diploma

Data Processing / Computer Programming 06/1980

Bergen County Vocational and Technical High School

AFFILIATIONS

American Society of Clinical Pathologist (ASCP)

Associate Member - 1988

Chicago, Illinois

National Society of Histotechnology (NSH)

Associate Member - 1988

Chicago, Illinois

United States Air Force (Sgt E-4)

Honorable Discharge - 1987

US Air Force Service Ribbon, US Air Force Small Arms Expert Marksmanship Ribbon, US Air Force Good Conduct Medal, NCO Preparatory Course Completion, Explosive Ordinance Disposal Training (Chemical Munitions)

CERTIFICATIONS

Fla DOH Licensed Clinical Laboratory Supervisor - 2002

ASCP Licensed Histotechnologist – 1984

CAP Laboratory Inspection Team Member - 2018

APERIO E-Slide Prognostic Image Analysis System - 2015

Digital Slide Image Transmission - 2015

ACIS Cellular Image Analysis & Documentation System Training - 2001

MediaLab CAPA/NCE Reporting Platform Training - 2019

Cerner "Co-Path" Laboratory Information System (LIS) Implementation & Administrator and User Training - 1994

SunPath Laboratory Information System (LIS) Implementation & Administrator and User Training

MediTech Laboratory Information System (LIS) - 2005

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