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Management Quality Assurance

Location:
San Francisco, CA
Posted:
March 09, 2015

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Resume:

Melissa Gordon Abbott

Quality Assurance Consultant, Principal Post Market Specialist

***** **** ***** ***** - ******** Springs, CO 80920

aconb5@r.postjobfree.com - 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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