1. HEATHER LAURIN
8232 Stone Mountain Road, Gosport, IN 47433 | 812-272-
6360 | heather_laurin@hotmail.com
SUMMARY
Quality individualcurrently seeking a positionwith a pharmaceuticalorbiotechnology
firm/research lab focusing on Supply Chain,Quality Assurance and/orQuality Control.
Previously at a contractmanufacturermanagingmaterialspecifications andcoordinating
manufacturing billof materials with fourteen years ofGMP experience.
EXPERIENCE
Oct 2014-Present Regulatory Coordinator, Engineered MedicalSystems, Indianapolis,IN
· Constructing andmaintaining CETechnicalFiles
· Preparation and support ofinternationalregulatorysubmissions
· Maintaining current regulatorystatus forcurrent products
· Maintaining regulatoryinformation required forproduct import purposes
· Preparation of510K premarket notification applications forsubmissionto FDA
· Preparation ofreports anddocuments to supportinternationalregulatory submissions
· Preparation ofdocuments and support ofactivities with Notified Bodies
· Participate in the assessment ofdevicechanges forregulatory implications
· Identifying neworrevised regulatoryrequirements,guidance documents andproduct
standards; conductinggaspanalysis when require
· Coordinating label/DFUrequirements and creationofproduct labels
Aug 2014-Oct
2014
Quality Associate, Baxter Pharmaceutical Solutions (Contractor for Kelly Services),
Bloomington,IN
· MasterBatch Record Quality Review
· Help with 6S projects fororganization within Information management department
· Workwith Validation department forChange controldocument verificationof
Migration fromTrackwise to BPLM
Nov 2013-Apr
2014
TeamCoordinator,TechnicalMaterialOperations,Cook Pharmica,LLC, Bloomington IN
· Provide management oversight ofspecifications forincoming raw materials and
componentsand finished products
· Serve as supervisorto TechnicalMaterialOperations Associates forcreation/revisions
for MaterialSpecifications andChangeControls forMaterialSpecifications
· Lead and drive MaterialReview Teams (MRT) as the subject matterexpert (SME) for
all materials related to the bill of material.
· Interface with client as Cook's Subject matterexpert (SME) for creating rawmaterial,
API, cell bank,component andfinishedproduct MSSs.
· Initiate and/orcoordinate Change Controls forMaterialSpecifications as needed

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· Revise standard operating procedures as needed.Provide training to other
manufacturing and TechnicalServices areas aboutmaterialrequirements
· Participate in or own process improvement projects
2009-2013 Quality ControlLaboratory Specialist/Quality ControlRawMaterialSpecialist, Cook
Pharmica,LLC ,Bloomington,IN
· Subject matterexpert (SME) for creating rawmaterial, API, cell bank,and finished
product MSSs.
· Coordinate outsourcedQuality Controltestingwith externallabs as needed
· Participate in MaterialReview Teams (MRT)
· Creating raw material, API, cell bank,and finished productMSSs.
· Quality Controlraw material testing accordingto applicable compendia
· Knowledge ofUnited States Pharmacopoeia Methodology European Pharmacopeia
Methodology Japanese Pharmacopeia andregulatory requirements
2006-2008 AnalyticalDevelopmentChemist, Kremers Urban/Schwartz Pharma, Seymour,IN
· Responsible fordeveloping,validating,transferring andwriting analyticalmethods for
raw materials and drug products.
· Also responsible forthe timely and accurate analysis offormulation and pre-
formulation samples fromthe PharmaceuticalTechnologySupport group.
· Write validation and transferprotocols and analyticalmethods.
· Document all laboratory testing andmaintain legible notebooks andrecords
· Knowledge ofcGMP, USP and FDA Guidelines
EDUCATION
2012 Survey ofRegulatory Affairs, Ivy Tech Community College, Bloomington,IN
1998-2001 Bachelor(Chemistry/Biology), College ofMount Saint Joseph, Cincinnati,OH
1992-1997 High SchoolDiploma, Carroll HighSchool, Dayton,OH
SKILLS
FDA and EMA regulatory compliance for material specifications
Good Manufacturing Principles
United States Pharmacopoeia Methodology (USP)
European Pharmacopeia Methodology (Ph Eur or EP)
Japanese Pharmacopeia (JP)
International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH)

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International Medical Device registrations
FDA UDI requirements
Microsoft Office Efficient
MES Syncade operating systems
eCDT technical Writing experience
Varian Dissolution Training
High Performance Liquid Chromatography Training (Agilent, Dionex and Thermo)
Dionex Chromeleon, Chemstation and Chemstore proficient
Analytical Method Development
Method Validation
Labware LIMS Administrator Certification V
Velquest SmartLab Procedure Execution
Velquest Smartlab Instrument Connections