Pamela Simone

** ********** ***

Shepherdstown, WV 25443

301-***-****

acwee5@r.postjobfree.com

Sanofi-Pasteur (Oxford Contractor) Swiftwater, PA Jun 2016-Jul 2016

Quality Consultant

Performed device history record review for product release to commercial distribution

Saint-Gobain Performance Plastics Gaithersburg, MD Jan 2016-Mar 2016

Quality Technician

Revised and mapped document control process

Revised CAPA procedure to implement a robust effectiveness check process

Implemented GMP training program

Developed training procedure and materials for revised good documentation practices

Performed GMP and good documentation practices training with all personnel

Performed device history record review and released product for commercial distribution

GKS Consumer Health (Oxford Contractor) St. Louis, MO Apr 2015-Aug 2015

Quality Consultant – CAPA Remediation over the counter pharmaceuticals

Revised and mapped CAPA effectiveness check process

Revised CAPA procedure to implement a robust effectiveness check process

Implemented improved CAPA procedure process to flow with investigation process

Developed training procedure and materials for revised CAPA process and effectiveness check

Revised deviation procedure to simplify process and flow with investigation process

Worked with site investigators to improve quality of deviation and CAPA investigations

Kremers Urban Pharmaceuticals (Oxford Contractor) Seymour, IN Dec 2014-Mar 2015

Quality Consultant – Complaint Remediation solid dose, powder, and foam pharmaceuticals

Evaluated, reviewed, investigated, and evaluated complaint investigations for closure

Investigated complaints and assigned all department investigations to multiple sites

Coordinated activities related to investigations

Covidien (Oxford Contractor) North Haven, CT Mar 2014-Oct 2014

Remediation Consultant – Complaint Remediation for mesh implants and surgical tools

Trained new personnel on complaint system

Received, entered, evaluated, and assigned complaint investigations to analysts for investigation

Investigated complaints and assigned all department investigations to multiple sites

Coordinated activities related to investigations

Prepared MedWatch responses to FDA to fulfill adverse event reporting requirements

Greatbatch (Oxford Contractor) Fort Wayne, IN Dec 2013-Mar 2014

Remediation Consultant – CAPA Remediation for supplier quality complaints of orthopedic implants

CAPA remediation project to evaluate current CAPA records for process improvement project

Prepare historical metrics for site CAPA regarding CAPA process effectiveness

Prepared reports summarizing metrics for process improvements for management

Covidien (Oxford Contractor) North Haven, CT Mar 2014-Nov 2014

Remediation Consultant – Complaint Remediation for mesh implants and surgical tools

Investigated complaints and assigned all department investigations to multiple sites

Coordinated activities related to investigations

Prepared MedWatch responses to FDA to fulfill adverse event reporting requirements

Updated complaint files for litigation files

Hospira (Oxford Contractor) Rocky Mount, NC Jul 2013-Aug 2013

Remediation Consultant – CAPA Remediation for Quality Environmental Laboratories

CAPA remediation project to evaluate current laboratory records for process improvement project

Prepare historical metrics for site CAPA regarding laboratory processes for environmental testing

Prepared reports summarizing metrics for corrective action for management

Synthes, USA (Oxford Contractor) West Chester, PA May 2013-Jun 2013

CAPA Consultant – CAPA and Complaints of orthopedic implants

CAPA and complaint remediation project to evaluate current systems for process improvement project

Prepare historical metrics for site CAPA and US sites complaint

Prepared reports summarizing metrics for corrective action and complaint systems for management

McNeil Consumer Healthcare (Validant Contractor) Fort Washington, PA Jun 2011-Apr 2013

Quality Analyst – External Supplier and Manufacturing Quality complaints for pharmaceutical products

Investigated complaints and assigned all department investigations to multiple sites

Coordinated evaluation of samples and investigation activities with multiple external manufacturing sites

Managed activities related to investigations including change controls, CAPA, and deviations

Assisted lead with monthly metrics

Assisted with annual product review activities including preparation and metrics

Prepared all investigation reports summarizing investigation results and corrective actions

QIAGEN (Manpower Contractor) Gaithersburg, MD Jul 2010-Dec 2010

IVD Document Specialist, IVD testing kits and testing equipment

Authored and coordinated approvals of user manuals, handbooks, package inserts, and other product labeling materials

Authored and coordinated approval of raw material specifications and production materials for women's health products

Worked on product teams with product development to bring product from R&D to commercialization

MedImmune Frederick, MD May 2005-Oct 2008

Product Complaint Specialist for vaccines and delivery systems

Applied Six Sigma for annual product complaints metrics

Performed software validation protocols for TrackWise upgrade

Coordinated report development for tracking product complaint investigation metrics

Investigated all complaints and assigned all department investigations to production multiple sites

Coordinated evaluation of samples and investigation activities with multiple production sites

Managed investigation files for archives and maintained investigation records

Prepared annual product reviews and prepared annual complaint metrics for all products

Prepared all investigation reports summarizing investigation results and related CAPA actions

Education

California State University, Fullerton, CA; Degree: BA in English

Cincinnati State Technical and Community College, Cincinnati, OH, Degree: AA in Business Administration

Certifications

Six Sigma Green Belt (Six Sigma.US)

Computer Skills

Microsoft: Word, Excel, Power Point, Project, Access, SharePoint, and Outlook

Adobe: FrameMaker, Illustrator, PageMaker

Other: TrackWise, Remetrex PQMS, EtQ, EDMS, LIMS, SAP, Citrix, Interleaf, Corel Draw

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