Quality Analyst
Resume:
Pamela Simone
Shepherdstown, WV 25443
***********@*****.***
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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