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Melissa L. Szwast
szwastme@hotmail.com
619-715-3051
Profile:
Results-oriented GxP Archival Specialist with more than nine 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-Dec2016)
Lead Archivist
 Maintain the document archives. This includes maintaining an index systemand 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 otherrelated duties as
assigned
 Followed Intertek SOPs, as they pertain to the archival system
 Revised SOPs, as changes are made to the archival system
 Created and archived reagent and equipment logbooks
 Followed GLP guidelines in the laboratory
 Assist with submission of periodic QA inspection reports to Study Director and/orTest Facility
Management
 Manage moving documents from onsite archival to offsite archival
 Harmonized SOPs for both Immuno Chemistry and LCMS
 Lead contact for giving tours of Archive Room to clients
 Possess a good understanding ofthe policies and procedures involved in records management
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 othergroups 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 ofstudy conduct are
included in the study files
 Manage the archiving of study files, wet tissues,blocks and slides from activities conducted internally and
externally
 Possess a good understanding ofthe policies and procedures involved in records management
 Develop a good understanding ofworking 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

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 Managing the paper laboratory notebookarchives, 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/orverification 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 ofstudy 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 ofthe policies and procedures involved in records management
 Develop a good understanding ofworking 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 notebookarchives, which includes issuance of notebooks,collecting,
logging and filing of notebooks upon return, coordinate with 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/orverification 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

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Arena Pharmaceuticals, Inc. San Diego, CA (January 2010 July
2010)
Document Control Associate I
 Supported the creation, revision and control of SOPs and othercontrolled 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 MasterSchedule 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
 Responsible for transmission of completed reports to appropriate personnelat 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 systemused 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 personnelwith 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)