Quality Assurance

Victoria Metzger

*** ******* ***** ************, *** Jersey 08691

732-***-****

acdwpx@r.postjobfree.com

SUMMARY OF QUALIFICATIONS:

Highly successful Quality auditor with a focus on document review, computer

systems application management and validation, training, laboratory

testing, and providing regulatory submission and audit/inspection support.

Proven record of performance that frequently exceeds expectations and is

supported by an ability to take on new tasks, learn them quickly, exercise

independent judgment and execute tasks with minimal to no supervision,

while maintaining a high level of productivity and quality and providing

excellent customer service/support.

PROFESSIONAL EXPERIENCE:

Hemispherx Biopharma, New Brunswick, NJ

Quality Specialist II, Quality Assurance (February 2014 to Present,

Contract Position)

. Coordinate the review and approval of site documents

. Manage and track training records using Train Track

. Track document metrics

Invensys Operations Management, Wyomissing, PA

Quality Reviewer, QA Validation (November 2012 to October 2013, Amgen

Project)

Provided Quality support for pre-approval, data review, and post approval

of development testing and computer validation function test protocols

and function test forms

Provided Quality support for engineering change management process by pre-

approving/approving Engineering Change Notices (ECNs)

Reviewed software testing documentation per design specifications

Reviewed requirements and automation design documents

Pre-approved test sets and post-approved test runs for Master Batch

Records (MBRs) calculations in HP Quality Center

Generated Requirements Traceability Matrix (RTM) and Validation Summary

Report (VSR) documentation

Validation Consultant, Regulatory Compliance (October 2011 to November

2012, Genentech Project)

. Reviewed and approved executed code review and test documents for Control

Modules & Equipment Modules

. Coordinated the review and approval of the following document types for

the Graphics Development Team: SOPs & Operator Interface Design

Specifications (OIDs)

. Oversaw storage and control of the following project documents: Training

Documents, Incident Reports, Change Records, Control Modules & Equipment

Modules (executed code review and test procedure/typical documentation)

. Managed and tracked Change Request and Incident Report documentation

. Assisted in the review and dry-run testing of OIDs in ArchestrA

Purdue Pharma L.P., Cranbury, NJ

Quality Specialist III, Research Quality Assurance (August 2007 to July

2011)

. Served as Site Application Administrator of the QUMAS DocCompliance

Electronic Document Management System (EDMS), responsible for the

following: assisting in issue resolution; conducting new hire and

refresher trainings; creating new user accounts; modifying account rights

and privileges; reviewing EDMS related SOPs and test scripts; submitting,

tracking, and making configuration changes using electronic change

controls and maintenance logs; performing test script execution for

various projects; creating site user manuals

. Participated in validation, upgrade, and migration activities for QUMAS

DocCompliance and SharePoint Document Management Database projects

. Managed a Cranbury Documentation Library SharePoint site and a Compendial

Compliance SharePoint site and oversaw user access, maintained site

content, and handled all inquiries/requests for both sites

. Attended vendor demonstrations and provided input on new computer

systems/applications of interest to the Cranbury site

. Coordinated the review and approval of the following document types for

the accomplishment of project objectives: Investigations, Planned

Deviations, Change Controls, CAPAs, Method Validation Protocols and

Reports, Notebook Methods, Test Methods, SOPs, Work Instructions,

Experimental Procedures, Stability Protocols and Research Specifications

. Reviewed laboratory notebooks and worked with analysts and/or management

to address concerns and trends

. Reviewed compendial publications on behalf of all Purdue sites and

delivered timely summary reports of potential impacts to ensure

compliance with USP monographs and test methods

. Reviewed stability and temperature charts and worked with Stability

Coordinator on issue resolution

. Provided support to multiple Purdue sites for FDA audits as well as DEA

and Corporate QA internal audits

. Assisted in data verification activities to support FDA regulatory

submissions and Corporate QA audits

. Tracked, issued, and scanned Analytical Sciences and Pharmaceutics

Department Laboratory Notebooks into the notebook repository, LibertyNet

. Developed an audit ready archival system for rapid retrieval of documents

and maintained all documentation stored in the Cranbury vault

. Created Certificate of Analysis (CoA) templates for Analytical Sciences

Department and issued Master Formula numbers

. Tracked Key Performance Indicators (KPIs) associated with review

activities at the Cranbury site

. Cross-trained and assisted in the review and approval of bulk, packaging,

labeling and assembly batch records

Fort Dodge Animal Health, Monmouth Junction, NJ

QA Auditor I, R & D Quality Assurance (May 2007 to August 2007)

. Performed protocol reviews and conducted on-site and off-site in-progress

phase inspections, and audits of raw data and final reports for GLP/GCP

studies

. Issued inspection reports, and followed up on required action items

. Assisted in the review and approval of audit reports and Quality

Assurance Statements

ImClone Systems Incorporated, Branchburg, NJ

Documentation Coordinator, Quality Assurance Document Control (September

2005 to May 2007)

. Prepared and routed documentation packages throughout the review and

approval cycle for groups such as Manufacturing and Quality Control

. Tracked document approval activities in the electronic document

management system Pilgrim

. Distributed approved documentation to appropriate personnel, tracked

receipt of documentation, and maintained distribution matrices

. Updated and maintained document tracking databases and archival systems

. Issued controlled Production Documentation to Manufacturing

QC Associate Analyst, QC Biochemistry (April 2004 to September 2005)

. Performed routine QC assays such as pH, Water Conductivity, Buffer

Conductivity, Osmolality, TOC, A280, IEF, SDS-PAGE, and ELISAs

. Sample coordination, including sample log-in and the compilation of EZ-

Req folders for the close-out process

. Archived Raw Data Result Binders and all EZ-Req file folders

. Handled result requests made by groups such as Quality Assurance Product

Disposition (QAPD) for A280, Bioburden, Endotoxin, Osmolality and Titer

data

. Entered Environmental Monitoring Software System (EMSS) data for daily

water samples

EDUCATION:

Bachelor of Arts in Biochemistry

Vassar College, Poughkeepsie, NY

May 2001

COMPUTER SKILLS:

Highly proficient in the following: Microsoft Word, Microsoft Excel, Power

Point, EMSS, Trackwise, Pilgrim e-library, Filetracker PRO, SAP, QUMAS

DocCompliance (QDCS), Liberty Net, Reliable Throughput Image Viewer (RTIV),

SharePoint, Wonderware ArchestrA Technology, Livelink Enterprise Content

Management, SAP Enterprise Learning (LSO), E-builder, HP Quality Center,

Train Track Employee Training Tracking Software, Adobe LiveCycle Designer

ES2

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