Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Employer
Certification
Hobbies and Interests
Timeline
Generic

Stephen Gaines

Maud,TX

Summary

I have held both laboratory management, quality management and Lean/Six Sigma related positions over 22 years with Vitalant (BSI) Reliable business professional with experience in project management, process improvement and financial analysis. Proven track record of successfully streamlining business operations and reducing costs. Adept at analyzing data to identify trends and developing strategies to improve efficiency. I have currently expanded knowledge of Medical Laboratory Sciences (MLS) by completing MS degree in MLS. My goal is to grow myself and the company that I work with.

Resourceful Compliance Auditor offering 15+year background conducting internal/external audits and thoroughly reviewing records to verify compliance to state and federal regulations. Systematic and moral professional with expertise identifying and documenting internal strengths and weaknesses and developing recommendations and corrective action plans. Strong communicator possessing clear, concise writing skills and proficiency in Microsoft Word.

Overview

27
27
years of professional experience
1
1
Certification

Work History

Quality Compliance Auditor

Vitalant (Blood Systems), Inc.
01.2011 - Current
  • Under minimal supervision, responsible for providing management with independent assessment of operations through performing internal audits and reporting results for Vitalant (BSI) and different business units
  • Drove organization’s internal auditing program to ensure compliance with applicable standards and regulations
  • Interfaced with regulatory/standard setting bodies such as FACT, ASHI, CAP, JC, AABB, IACUC, along with regulatory requirements such as CLIA and FDA (cGMP/GCP/GLP)
  • Supported development and deployment of Quality System for the enterprise Clinical and Research activities
  • Participated in final decisions regarding evaluation of nonconforming products, materials, or test results.

Quality Source Consultant

Vitalant (Blood Systems), Inc.
02.2010 - 05.2013
  • Performed Gap analysis inspections for hospital customers as well as other blood centers not under Vitalant (BSI) umbrella
  • Gap audits included AABB, FDA, CAP, CLIA, ASHI, and TJC
  • Functioned as operations consultant when required for blood centers
  • Made visits to blood centers and hospitals to assist with opportunities for performance improvement
  • Developed training and Standard Operating Procedures for hospital clients and internally with Vitalant
  • Collaborated with customers to establish and maintain key relationships between Vitalant and hospitals
  • Worked on multiple projects with customers that include Lean, Six Sigma, GMP training, Review and Rewriting of Transfusion Services Supervisor Handbook, PACE accredited training, and CEUs
  • Collaborated with both internal and external customers on requests regarding consideration of new product offerings, as well as leading and facilitating cross-functional team for analysis, assessment, and recommendation based on findings.

Manufacturing Process Specialist

Vitalant (Blood Systems), Inc.
04.2017 - Current
  • Responsible for being the subject matter expert (SME) related to procedures (SOPs), equipment, and processes
  • Maintained the blended role of functioning as Process Improvement Specialist (OE/PSI)
  • Took part in meetings with the National Office and Divisional meetings in which guidance was given to the field and national office relating to quality, Lean/Six Sigma, and system improvements.

Lean/Six Sigma

Vitalant
01.2007 - Current
  • Developed and led Lean and Six Sigma groups
  • Helped implement Lean Six Sigma projects by gathering operational information.
  • Provided program management expertise in lean Six Sigma strategies and agile methods, practices and execution.
  • Developed and presented regular reports, insights, and communications to key stakeholders on product status, schedule, and capacity for the area of operation
  • Participated with corporate, regional, and local teams to meet goals.

Laboratory Manager

United Blood Services
01.2002 - 01.2007
  • Managed performance of record review, QC testing, labeling, antigen screening, antibody identification, and all blood component processing within UBS-TXK center
  • Supported thirty-three hospitals for special testing and blood component distribution.

Medical Technologist

Multiple Hospitals
01.1997 - 01.2002
  • Performed crossmatches, antibody screens, antigen testing, cord blood profiles, and special antigen/antibody evaluations in Blood Bank
  • Performed fungal, bacterial, mycobacterium identification and testing including antibiotic resistance in Microbiology. Performed serology testing as well.
  • Performed laboratory processing in all areas of laboratory as generalist.
  • Assisted Pathologist on bone marrow extraction, preparation and review.
  • Assisted in autopsies and tissue preparation and evaluation.
  • Performed both cell block preparation and review of slides.

Pharmacy Technician

Christus St. Michael Hospital
01.1997 - 01.2002
  • Performed order fulfillment and delivery in inpatient environment for medications
  • Worked with pharmacist to make in-house IV fluids.

Education

MS-Medical Laboratory Sciences -

University of North Dakota
01.2023

MBA - Business

Texas A&M University
Texarkana
01.2010

BS-Medical Technology -

University of Arkansas For Medical Sciences
Little Rock, AR
01.1998

Skills

  • Quality Assurance
  • Analytical Thinking
  • Subject Matter Expert
  • Project Leadership
  • Performance Tracking
  • Configuration Management
  • Requirements Gathering
  • Cost Analysis
  • Process Optimization
  • Strategic Planning

Accomplishments

  • Supervised multiple teams with staff members between 5-30 staff members.
  • Achieved reduction of expenses by completing projects which improved accuracy and efficiency. One project saved the company one million annually.
  • Achieved redesign of multiple laboratories and quality function through effectively helping standardizing and lean local processes.
  • Achieved improved quality by introducing software for equipment management and temperature monitoring for the company as the subject matter expert in maintenance and monitoring.
  • Documented and resolved multiple site specific and Vitalant wide quality issues which led to less compliance concerns.
  • Collaborated with team of 15+ in the development of internal auditing process development..

Affiliations

  • Registered Clinical Laboratory Scientist (CLS) with the American Society of Clinical Pathologists (ASCP)
  • Member of the South-Central Association of Blood Banks (SCABB)
  • Member of the American Association of Blood Banks (AABB)
  • Member of the American Society for Quality (ASQ)
  • Certified Black Belt in 6 Sigma
  • Certified Lean Facilitator
  • Member of Thrombosis & Hemostasis Societies of North America (THSNA)

Employer

Vitalant:  Leader in experience, practice and application of transfusion medicine.

  • Cellular Therapy Laboratory (CTL): TNC, CD3, CD34, CD45, Colony Forming Unit.
  • Other Laboratory: Immunohematology Reference Laboratory (IRL), Human Leukocyte Antigen (HLA), Coagulation studies and support.
  • Cell Sourcing: Hematopoietic Stem Cell Collection (HPC), Cord Blood processing and storage.
  • Research: Immunology, Molecular Transfusion, Viral Laboratory & Repository, Cell Therapy, and Epidemiology.
  • Blood Products: Whole Blood, Platelets, Plasma, and Cryoprecipitate. The second largest blood services provider in the nation, Vitalant distributes a variety of blood components and products to our healthcare partners around the country for transfusion

Certification

  • Certified Medical Technologies, - American Society of Clinical Pathologists (ASCP).
  • Certified Lean/Six Sigma Green Belt- American Society for Quality (ASQ)


Hobbies and Interests

I enjoy traveling and as an auditor I have visited over 100 hospitals and blood collection facilities in 38 states.  We own a 5th wheel camper and try to spend 1-2 weekends at the lake each month.  We support the local school by volunteering during games.  We served as foster parents and adopted a child.  Prior to that we hosted an exchange student from Russia.  I served on the city council for 3 years and was elected to the county chair.

Timeline

Manufacturing Process Specialist

Vitalant (Blood Systems), Inc.
04.2017 - Current

Quality Compliance Auditor

Vitalant (Blood Systems), Inc.
01.2011 - Current

Quality Source Consultant

Vitalant (Blood Systems), Inc.
02.2010 - 05.2013

Lean/Six Sigma

Vitalant
01.2007 - Current

Laboratory Manager

United Blood Services
01.2002 - 01.2007

Medical Technologist

Multiple Hospitals
01.1997 - 01.2002

Pharmacy Technician

Christus St. Michael Hospital
01.1997 - 01.2002

MS-Medical Laboratory Sciences -

University of North Dakota

MBA - Business

Texas A&M University

BS-Medical Technology -

University of Arkansas For Medical Sciences
Stephen Gaines