Management Quality Assurance
Resume:
Melissa Gordon Abbott
Quality Assurance Consultant, Principal Post Market Specialist
***** **** ***** ***** - ******** Springs, CO 80920
*********@*****.*** - 719-***-****
Highly motivated, disciplined, professional with the ability to manage and prioritize multiple projects
simultaneously. Over 20 years of experience within the life sciences community. Proven ability to establish strong
working relationships with internal and external teammates. Develops and implements quality programs to include
complaint handling, CAPA and trending. Acquires and analyzes data using appropriate standard quantitative methods
across a spectrum of business environments to facilitate process a nalysis and improvements.
WORK EXPERIENCE
Quality Assurance Consultant, Principal Post Market Specialist
Validant Consulting – W altham, MA – October 2014 – present
Act as a mentor and provides guidance to fellow staff members related to complaint class based on the master
symptom code severity list. Mentors staff members regarding complaint processing. Acts as a go to resource for the
department staff members on complex complaints.
Acts as a lead within the PMS department for all PMS duties and CAPA rel ated responsibilities.
Responsible for SOP revisions/document creation/annual document review as assigned.
Review/Approve complaints for file closure. Monitors and reports on complaint closure metrics as required.
Ensures complaints are processed in a uniform and timely manner, whether they are equipment, drug or device
origin, and oral complaints are documented using good documentation practices (GDP).
Responsible for receiving, reviewing, entering, evaluating data into the Complaint Management Database regarding
customer/patient product inquires and complaints and further processing complaint files. Interfaces with Customer
Service and clinics/patients to gather additional information required for complaint investigation, including product
sample returns. Provides training during orientation and on -boarding of new staff.
Applies knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance
MDR/ADE reporting decision process within regulatory timeframes. Responsible for the completion of MSR/ADE
decision trees and is able to complete complex MDR submissions. Understands the Field Alert Reporting (FAR)
process and evaluate, distinguish and recommend complaints for FAR reporting. Recognize complaint trends and is
able to present related information to management. Provides coding support, reviews and updates in the Complaint
Management Database. Determines product and incident complaint codes and responds to questions. Notifies
customers and prepare customer/patient communication as appropriate. Partners with Sales, Marketing and
Manufacturing departments to resolve product problems and provides feedback to the customers as needed.
Interfaces with Corporate Quality Engineering and the RTG manufacturing sites as required f or product investigations
and trend reporting. Assists management with work flow specialist assignments.
International Compliance and Quality Consultant
Maetrics, LLC - Zuchwil, SO - November 2013 to October 2014
Responsibilities
Specializing in Complaint Management Remediation
Audit, Review and Verification of Field Service Records
Quality Assurance Contractor
Cochlear Americas - Colorado Springs, CO - June 2013 to November 2013
Specializing in Complaint Process Management
Class III medical device SME
Trainer and Facilitator
Senior Quality/Post Market Surveillance Analyst
Spectranetics Corporation - Colorado Springs, CO - April 2008 to March 2013
Post Market Surveillance SME during 3 FDA, 2 BSI and 1 TUV Audits
CAPA Root Cause Analysis, KT Analysis, Implementation, & Verification
Supervised the work of entry-level analysts for 3 years
Maintain & Audit complaint files and Adverse Reporting
Developed and Supervised the Failure Analysis Engineering Lab
Used statistical tools to drive analysis, evaluations and quality decisions
Program Development/Management
GMP, GLP, GCP, 21 CFR Part 820, 198, and 803
ISO Regulations 14971, 13485
Strong interpersonal and communication skills
New hire trainer
Reduced mortality rate in 2012 by the implementation of the Complication, Prevention & Management program
Implemented clinical trial/complaint database
Microsoft Office, Word, Excel, Agile, Lotus Notes, eSubmitter FDA
Owner/Psychotherapist
Ascension Therapeutics - Colorado Springs, CO - March 2009 to June 2011
Chronic Addiction, Situational Crisis Therapy, Individual and Marriage Counseling to include active military,
teen/young adult and adult clients.
Clinical Psychiatric Liaison
St. Mary-Corwin Hospital - Pueblo, CO - October 2006 to January 2009
Member of a multidisciplinary Pain Management and Trauma Team, Utilization Reviews of all Pain
Management Patients, DSM Diagnosis, Crisis Intervention/Stabilization, Drug and Alcohol evaluations,
Discharge Planning, Mental Health Holds, Drug/Alcohol Holds, Transferring/Placement of Patients
Emergency Medical Technician
Penrose Hospital - Colorado Springs, CO - June 1998 to January 2008
Direct patient care to include trauma, orthopedic, cardiac, and wound care, Member of Trauma Team, Patient
care documentation/basic status assessment/transport, ER IV team - IV therapy for patients with difficult vasculature.
Safety Specialist
Training Resources Consultants - Colorado - June 1998 to January 2008
Responsibilities
Confined Space Rescue Training to include Basic First Aid, Industrial Hearing Evaluations and Testing, MSDS
Auditing, Industrial Manufacturing Safety Audits
Skills Used
Respiratory Fit Testing
Occupational Hearing Testing
EDUCATION
Masters in Community Counseling
University of Phoenix CO Campus - Colorado Springs, CO
EMT - Basic in Emergency Medical Technician
Aims Community College - Greeley, CO
Bachelors in Psychology
University of Southern Mississippi - Hattiesburg, MS
Associates in Pre-Nursing
Hinds Community College - Raymond, MS
SKILLS
CATSWeb, Agile, Lotus, Microsoft Office/Excel/Word, FDA eSubmitter, SharePoint, EtQ, Pilgrim
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