Resume

1. Melissa L. Szwast
Profile:
Results-oriented GxP Archival Specialist with more than eight years of experience in the
pharmaceutical industry. Self-motivated, with excellent organizational, written and verbal
communication skills. Excellent team player with the ability to perform above and
beyond expectations in a demanding, high-paced environment. Knowledgeable in FDA
regulations, GxPs, Standard Operating Procedures and in monitoring, tracking and ensuring
GxP compliance.
Employment History:
Intertek Pharmaceutical Services San Diego, CA (November 2015-Current)
Archivist
 Responsible for maintaining the document archives. This includes maintaining an index
system and placing in the archive all raw data, reports, protocols, and final reports at
study completion
 Perform general administrative functions, such as making photocopies, filing, scanning,
and other related duties as assigned
 Responsible for following Intertek SOPs, as they pertain to the archival system
 Responsible for updating SOPs, as changes are made to the archival system
 Responsible for creating and archiving reagent and equipment logbooks
 Responsible for following GLP guidelines in the laboratory
 Assist with submission of periodic QA inspection reports to Study Director and/or
Test Facility Management
 Responsible for moving documents from offsite archival to onsite archival
Arena Pharmaceuticals, Inc. San Diego, CA
Quality Assurance Unit Archivist III (July 2015-October 2015)
 Lead point of contact for all archiving with CROs
 Assisting other groups in reducing the yearly archival cost for the company
 Managing the scanning/verifying of paper raw data to reduce paper and storage
space for archiving
 Manage the retrieval of documents, both physically and those stored on
computers and preparing them for permanent storage
 Interact with study directors, study monitors, PI’s, and QAU to ensure that all
aspects of study conduct are included in the study files
 Manage the archiving of study files, wet tissues, blocks and slides from activities
conducted internally and externally

2. 2
 Possess a good understanding of the policies and procedures involved in records
management
 Develop a good understanding of working in a GxP environment and becoming
familiar with all relevant SOPs, especially those regarding archiving data, to
ensure a high level of compliance by the division
 Manages historical CRO and department GxP documents
 Trains new employees on the policies and procedures of archiving
 Track and communicate reports for Arena QAU using SharePoint. Ensures
appropriate responses to the observations that have been received, closed and
completed in conjunction with QAU auditors
 Managing the paper laboratory notebook archives, which includes issuance of
notebooks, collecting, logging and filing of notebooks upon return c
 Manage and coordinate with outside organization for scanning of notebooks and
LDRs, and retrieval of notebooks when corrections or copies are required
 Manage, compile and archive relevant correspondence specific to GLP nonclinical
and clinical studies
 Manage, compile chart recorder data, route for QA review, log and file data
following review
 Responsible for various administrative tasks as needed
 Lead support with document control requests for Material Specifications
 Support Document Control with logging, scanning and filing of various documents
 Automation and/or verification of PDF forms
 Full administrative rights in SharePoint
 Developed a KPI (Key Performance Indicator) metrics for tracking review and
turnaround time for review of GLP/GCP documents
Arena Pharmaceuticals, Inc. San Diego, CA
Quality Assurance Unit Archivist II (July 2013-July 2015)
 Responsible for retrieving documents, both physically and those stored on
computers and preparing them for permanent storage
 Interact with study directors, study monitors, PI’s, and QAU to ensure that all
aspects of study conduct are included in the study files
 Play the key role in archiving study files from activities conducted internally and
externally
 Possess a good understanding of the policies and procedures involved in records
management
 Develop a good understanding of working in a GxP environment and becoming
familiar with all relevant SOPs, especially those regarding archiving data, to
ensure a high level of compliance by the division
 Serve as a resource and referral for historical and department GxP documents,
and would train new employees on the policies and procedures of archiving
 Serve as a resource and referral for historical and department GxP documents
 Track and communicate reports for Arena QAU using SharePoint. Ensures
appropriate responses to the observations that have been received, closed and
completed in conjunction with QAU auditors
 Maintain the paper laboratory notebook archives, which includes issuance of
notebooks, collecting, logging and filing of notebooks upon return, coordinate with

3. 3
outside organization for scanning of notebooks and LDRs, and retrieval of
notebooks when corrections or copies are required
 Compile and archive relevant correspondence specific to GLP nonclinical and
clinical studies
 Compile chart recorder data, route for QA review, log and file data following
review
 Responsible for various administrative tasks as needed
 Lead point of contact for all archiving with CROs
 Lead support with document control requests for Material Specifications
 Support Document Control with logging, scanning and filing of various documents
 Automation and/or verification of PDF forms
 Qualified one of two color scanners for department
 Full administrative rights in SharePoint
Arena Pharmaceuticals, Inc. San Diego, CA (July 2010-July 2013)
Quality Assurance Unit Archivist I
 Assisted in the binding of the printed, wet signed electronic laboratory notebooks
and associated LDRs
 Responsible for printing, filing and archiving of all GLP study correspondence
 Participated in multiple mock FDA GLP Audits as Document Lead to help ensure
inspection readiness
 Assisted in the automation and/or verification of PDF forms
 Compile chart recorder data, route for QA review, log and file data following
review
 Support document control with the DCR requests for Material Specifications
 Support document control with logging, scanning and filing of various documents
 Document distribution of all controlled documents
Arena Pharmaceuticals, Inc. San Diego, CA (January 2010July 2010)
Document Control Associate I
 Supported the creation, revision and control of SOPs and other controlled
documents
 Maintained Controlled Copy binder stations
 Supported the Document Control Review Board
 Issued employee training packets for new and revised SOPs
 Retrieved documents requested during the 5-Day FDA GLP Inspection
 Logged and filed documents
Arena Pharmaceuticals, Inc. San Diego, CA (2007 to 2009)
Quality Assurance Unit Archivist I
 Responsible for archival, maintenance and retrieval of internal and external GLP
documents
 Inventoried, logged and filed Raw Data for archiving
 Maintained the Master Schedule and workflow schedules within Arena’s Quality
Assurance Unit
 Tracked GLP documents submitted for review to ensure appropriate responses to
the observations have been received, closed and completed in conjunction with
QAU auditors

4. 4
 Responsible for transmission of completed reports to appropriate personnel at
contract research organizations and internal departments
 Required to maintain familiarity with FDA GLP regulations and Company Standard
Operating Procedures to ensure a high level of compliance
 Implemented and managed a new system used for tracking GLP Documentation
through the QA-GLP group including Protocols, Reports, Facilities Documentation
including equipment and validation, electronic and raw data and Test articles,
Investigation and Enforcement documentation
 Maintained multiple internal databases to ensure the timely processing of incoming
documents related to Arena’s GLP activities
 Member of Project Team to Implement Corporate Electronic Repository (Livelink)
 Responsible for the centralization, final verification and filing of all documentation
related to GLP studies to assure regulatory compliance
 Assisted various administrative personnel with additional projects and tasks as
needed including verification of automated forms
Education
 New Horizons (Excel and Word, San Diego, CA)
 QuickStart (Introduction to SharePoint 2013 for Collaboration and Document
Management)