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Theresa (Terry) Dumont

New Bedford, MA 02745 | 508-991-1136 |

Quality Assurance Specialist: 2016 MBA graduate. Member of the American Society for Quality. Highly competent,
enthusiastic, goal-oriented professional with a passion for quality and the improvement of health-related outcomes.
Core Competencies:
Quality System Regulations
Team Leadership

Data Analysis

Problem Resolution
GMP Training

Project Coordination
Lean Thinking

Employment History:

2012 2014

Systems Analyst II

2004 2012

Quality Assurance, Regulatory Compliance | Regulated Systems Manager


2000 2003

Associate Scientist

1998 2000

Associate Scientist, Center for Adaptation Genetics and Drug Resistance


1996 - 1998

Medical Laboratory Technologist

Experience, Skills and Achievements:
Quality Assurance & Regulatory Compliance
Quality Assurance and Regulatory Compliance subject matter expert for the collection, manufacture, and distribution of
blood products.
Researched, interpreted, and determined the relevancy of various regulations, standards, and guidelines to blood center
Planned, coordinated, conducted, and closed Internal Quality System (QS) Audits to ensure blood center operations
were in compliance with government regulations, standards, and company-wide Quality Assurance and Regulatory
Compliance policies and procedures.
Reviewed and approved all equipment, process and system validations, standard operating procedures, and other
internal documents to identify existing and potential causes of non-conformance with all regulations and standards
governing blood establishments.
Investigated non-conformities; Participated in root cause analysis; Issued & reviewed CAPAs and conducted
subsequent effectiveness checks.
Served as a subject matter expert for the implementation of the ISBT 128 global standard for the identification, labeling,
and information transfer of blood products of human origin.
Developed, documented, and enforced policies and standard operating procedures for regulated system administration,
change management, and error reporting, investigation, and resolution.
Trained blood center employees in current Good Manufacturing Practices (cGMP), OSHA regulations (e.g. Blood
Borne Pathogen regulations), and Latex awareness.

Improved quality performance and compliance by participating in the planning and coordination of quality management
and improvement programs across several blood center locations.
Served as project lead and subject matter expert during the implementation of regulated systems used in the collection,
manufacturing, and distribution of blood products.

Assisted in the development of regulatory medical device submission documentation: hazard analysis, traceability
matrix, product release description, document inventory, design history file and other design control documentation.
Performed gap analysis between two blood establishment computer systems to identify any functionality that might be
present in the original system scheduled to be retired but missing from its replacement system.
Served as the blood centers regulated systems manager with the responsibility of ensuring that systems remained in a
validated state, in compliance with regulations and standards and met corporate and end-user requirements.
Served as a cross-functional team member involved in the design and development of a web-based hospital blood
ordering system and an in-house, web-based, event reporting and change control system.
Served as a member of a software vendors Technology Working Group to participate in the design of blood
establishment computer software that would be capable of meeting changing regulatory and business requirements.

Health Care & Scientific Research

Designed, validated, and implemented antimicrobial and antifungal assays, in vitro micro-dilution assays and in vitro
mammalian cell toxicity and absorption assays for antibiotic drug development.
Analyzed, reported, and presented antibacterial, antifungal, cytotoxicology, and absorption experiment data to lead
scientists and corporate executives.
Served as a cross-functional team member in the development of omadacycline, a first-line monotherapy for serious
community-acquired bacterial infections.
Participated in a research grant that involved the collection, preparation, isolation and identification of bacteria and
fungi found in the typical home in an effort to determine the effects of daily or intermittent use of anti-bacterial products
in kitchens and bathrooms.
Analyzed experimental data, interpreted results, and transferred findings into a description of the effects of anti-bacterial
product usage in the home, looking specifically for any effect on the typical microbial flora and their numbers, and any
signs of prokaryote adaptation to common antibiotics as a result of exposure to these products.
Prepared and analyzed body fluids and other biological samples and prepared blood, plasma and platelets for transfusion
following blood group and compatibility testing and ensured continuous, effective and efficient operation of analyzers
and other critical laboratory equipment.
Education, Training & Memberships:
Masters in Business Administration with a focus on Healthcare Operations, Lean Operations in Healthcare, and
Corporate Social Responsibility, May, 2016, GPA 3.82
Bachelor of Science: Medical Laboratory Science, 1996, GPA 3.82
Masters Certificate: Business Analysis, 2011
Additional Education includes the following subject matter: University of Villanova: Project Management; Colorado
State University: Regulatory Affairs for the Medical Device Industry, IVD and Human Tissue Industry & Quality Systems
& ISO 13485 Regulations. Currently preparing for the ASQ Pharmaceutical GMP Professional certification.
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