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Desiree Bartley 06_29
- 1. Desiree Bartley
DESI6@optonline.net 845-304-6551
SUMMARY
ProvenQualityControl Samplerwithover10 yearsof experienceinthe pharmaceutical industryincludingbiotech,
consumerhealth,andcosmetics manufacturing. Proficientin Aseptictechniques includingenvironmentalsampling and
relatedQA/QCactivities. CertifiedinClean-roombehaviorandasepticgowningpracticesandprocedures withfocuson
ensuringcompliance utilizingGoodManufacturingPractice (cGMP),FDA regulations,StandardOperatingProcedures,
corporate policies,andsafetypractices. Environmental monitoring (EM) subjectmatterexpert (SME) and designated
trainer.
Key skills:cGMPs, LIMS, EM monitoringSME,SAS,MetOne,Aseptictechnique.
Accomplishments
Temporary Supervisorexperience (6months). Schedule personal andarrangedstaffingtoensure appropriate production
coverage. Collaborate with the operationsteams forproblemresolutionregardingroutine production issues. Recipient
of multipleemployee recognitionawards includingthe Aseptic‘TopGun’performer,‘Above and Beyond’,‘Ownit’ and
‘Employee of the Month’awards.
EXPERIENCE
Pfizer – Pearl River, NY 2003 – Sept.2016
Quality Control Sampler, QualityControl
Performqualitycontrol activities insupportof the productionof sterile vaccines(Prevnar). Direct/guide/leadall
associated EMactivities fortwofill/finish asepticmanufacturingareas(vial &syringe).Performroutine personnel
auditsto ensure site wide gowningqualification requirements. Performenvironmental monitoringperformance
qualifications(EMPQ) andannual requalifications.
Schedule andsupportall batchrelatedEMactivitiesfortwosterile fillinglines.Ensure weekly,monthly,quarterly,
semi annul andannual EM requirementsare metfor all productionand supportingareas. Performpersonnel
monitoringforemployeesworking inasepticenvironmentstoensure, cleanroombehaviorcompliance and
productintegrity.
Execute environmental monitoringutilizingReplicate OrganismDetectionandCounting(RODAC) mediaforthe
collectionof surface samplesand viable airmonitoringusingthe Surface AirSampling(SAS). Collectnon-viable
airborne particulates utilizingMetOne. Performswab, directInoculation,fungi,andanaerobicsamplingof area
and equipment ona quarterly,semi-annual,andannual basistoensure integrity.
Use Citrix Labware,LACES/LIMStoinitiate chainof custodyandmaintainaudittrail forEM samplesincluding
documentationandmetadataentry.
Evaluate cleaningeffectivenessof asepticprocessingareasforweekly,monthly,quarterlyandsemi-annual
inspectionsandaudits(routine).
Qualifyforandmaintainasepticgowncertification foraccesstoclassifiedenvironments. Participate inmedia
simulationstoperform interventionstomaintainjob qualification.
Utilize instrumentationincludingMetOne Particle Counter,Dew PointAnalyzer,andSASSuper 100 Sampler,
Visaliahadheldtempandhumidity
- 2. Avon Cosmetic Company - Suffern, NY 1996 – 2003
Raw Ingredient Sampler, Quality Control 2000 - 2001
Receivedsamplesandreleasedrawingredient metadataintosystem;Issuedcontrol numbersandapprovals
DeliveredrawingredientstoQualityAssuranceand microlabs.
Production Assistant 2000 - 2001
Staffedproductionlines andtrainednewemployees.
Retrievedand enteredproduction line information intocomputersystem.
Machine Operator 1996 - 2000
Operatedproduction machinery forall products.
Computerskills:Citrix (LabWare,LACES,andLIMS),Novell, PlateauandWord
EDUCATION & TRAINING
Training: cGMP, Safe Start, HazardousMaterials(HazMat)
Certifications: AsepticGowning(all classifications)
NyackHigh School,RegentsDiploma
ProficientinandfamiliarwithcGMP,USP,FDA,EMA, OSHA and EPA guidences