1. Mark Quinton
2 GleannAnOir, Shannon,Co.Clare. Mobile:085-8276127
E-mail:markqu2003@hotmail.com
SUMMARY
Skilled and PractisedProcess Supervisor and Operator,witha WideExperienceoftheChemical, Pharmaceutical, MedicalDevice andLight
Engineering Industries,Highly Trainedin Delivering QualityOutput ina Regulated EnvironmentProfessional inApproach, with a TrackRecordof
Taking Responsibility andLeading Teams in Achieving Results.Very Self-Motivatedwith a Logical Approach to Work.Enjoys Environments
where there areOpportunities toLearnnew Skills.
EXPERIENCE
Medtronic, Galway. January 2010 – October 2010 January 2011- Date
A Global Leader in MedicalDeviceTechnology,MedtronicGalway isthe main producer of Bare and Drug Coated Stentsand Delive rySystems
for Medtronic Worldwide.
DES Fusion Cell
My role is to performa setnumber ofworksteps withintheFusion Cellto achievetheproduction ofa completely finished drug-coatedstent
packagedand ready for sterilisation. Production to FDAStandards; GMP and GDPapplied.
• Line Clearance: removalofallprevious batch materialoffthe line, Cleandown, sterilise the lineinpreparationfor thenext
batch ofstents.
• Set up ofbatches for cellproduction –swatsystem, AS400 system
• Perform the following worksteps within thecell
• Pre-weigh –Weighing ofstents prior tostents being coated bydrug
• Wet-weigh / Inspect Dry-weigh/ Inspect –Weighing and inspection ofstents afterdrug coating undermicroscopefor any
damage andPass or Reject Stents byapplying failurecodes to rejectedproduct
• Load/Label Vial–Passedstents after Dry inspect areplacedin vials in preparation for the next workstep and identified by
the labelling ofvials.
• Final Inspect–Inspection ofstent andcatheter prior to finalpackaging ofproduct andPass or Reject Stents / Catheterby
applying failurecodes torejected product
• Accessory Attach –this is wherethestent andcatheterareassociated together and various pieces ofequipment attached
to the unit e.g. identification chart priorto packaging
• Pre-eto / Urania –This is where the completed unitis packaged and sealed and Labelledinto specific pouches andplaced
into boxes to besent for sterilisationand shipping
• Ensure ProductBuilding Targets are met,and document allworkdoneduring shift
• All relevantPaperwork investigate any issues as theymay arise
2. • A3s / DMAIC –This is a process that allows toreportand improve any issues which may arisewithin the cell and allows us
to continuously improve systems within the cell infrastructure
UCB Schwarz Pharma, Shannon
Wholly owned subsidiary of BelgianGlobal PharmaCompany, UCB.UCBis aglobal biopharma business focusing on severediseases in two
therapeuticareas-CNSandImmunology.
Chemical Process Operator
My role is to monitor andcontrol theproductionof5ISMand ISDN in the Nitration and Pharma Plants;theseareused to treat heart disease.
Production toFDAStandards; GMP and GDP applied.
• Record andmonitor manufacturing process steps fromSCADA( ComputerisedcontrolledSystem)
• Identify current status ofBatch Manufacturing Process by conducting shift handovers at the beginning and end ofshifts
• Obtainedand reviewed the relevant Batch Manufacturing Instruction(BMI) to checkstatus ofthemanufacturing process
• Nitration Process Entailed: RawMaterial Loading; Hydrolysis; Separation; Distillation; Purification; Centrifuging;Drying; Unload to
drums; Move toStorage; Preform correctCleaning procedures onplantand equipment
• Pharma Process Entailed: Dispensing; Milling ofProduct-Particle sizing and Sampling; Blending; Unloading productfrom blenders;
Sieving; Preform correct Cleaning procedures on plant andequipment
• CalibratePH metres andrecordresult in Log Book and BMI
• RetrieveSamples for QualityControlTesting ThroughouttheProcess
• Use ofP.P.E. whererequired
• Cleaning ofallRooms, MachineryandEquipmentto Various Cleaning Levels as required
• Identify and investigateany problems or blockages in themanufacturing process and advise supervisorifandwhen a Deviation
Report is necessary
• TransportProducts to andfrom Warehouseby fork truck,All material movements governed by SAP
• Maintain communicationbetween Production, Laboratories and Warehousethroughout Batch Ma nufacturing Process
• Review and ReviseNitration PlantS.O.P’s
• Training ofnewoperators ofthe manufacturing processes
• Validation ofequipment, processes and machinery
Fabricated Products, Shannon
• Light Engineering, MetalFabrication
General ShiftSupervisor
• Superviseevening/night shift 20-70 operators; Train allnewOperators
• Liaised withplant manager re. Stores,Planning and Quality
• Set-Up ofTrumpfMachines
• Preform allMachineMaintenanceon TrumpfPneumatic Punching Machines
• ReplaceHydraulicleads,MachineHead, sensors and service Trumpfmachines as required
3. • Investigate andresolveall production down timeissues; Issue reports as required
EDUCATION AND DEVELOPMENT
Carpenter Apprenticeship withMc’Inerney Homes -1990-1993St.Caimin’s Community School Inter and Leaving Certificate 1985-1990
Diploma in WorkplaceSafety And Health
Diploma in Project Management
UCB SchwarzExtensive high quality training programmes:
GMP - Documentationand Guidelines; Logbook/BMI GDPRequirements for Operations; Manufacturing toS.O.P.s;EHS Awareness-ISO 14001;
Forklift CounterbalanceLicence; Bund &Drainage Management; OzonationofPurified Water System; Production planning andexecution;
Scheduling a batchrecipe; SAP Navigation Training; SAP systemend usertraining - Production& Planning Module -Production Execution;
Asphyxiation training; ManagementofAncillaryEquipment; Equipment Handover; AlarmManagement inSP3;Operation ofCentrifuges;
Manual Handling Training; AtmosphericEmissions CMS; Safe OperationofMotorisedPallet Truck; SiteRules andRegulations;FireExtinguisher
Training; Intermediateand FinishedGoods; Safety Handling ofChemicals; ParticleSize Sieve; EasyLabel MultiUser System;Managementof
Gowning; Filling & Labelling Containers; OperationofLaminar FlowBooth; Labelling ofEquipment & Materials inOperations; Gas detector Use
& Nitrogen Vacuum Release;DecontaminationofWastenitricacid; Issuing BatchNumbers;In-Process controlprocedure; Material movement;
Shift transfer/ handover;UseofMicrosoft excel spread sheet for calculations in Nitrates; Useofprocess order traveller document; Completion/
Checking of BMR'S; Disposalofrecovered solvents thatdo notconformto IPC's; TransferofMaterials to Production; OperationofSampling
Devices; Tank Farm Sampling; Calibration ofPHProbes; General PPEFor Process Areas; Non routineoperations; VisualChecking ofISDN/GTN
Spray Bottles; Handover ofprocess equipment prior to a shutdown; EquipmentUseLogs; Removal OfDryer Filter Bags; Entry To ServiceAreas
From IsolationAreas; Methods OfSampling; Capsule Filler;
PERSONAL
• Computer Skills: ECDL;SCADA; SWAT; AS400; SAP KEYUSER
• Date ofBirth: 11th May 1973
• Interests: Sport-Hurling,Rugby;Swimming; Irish Dancing-Son participates atInternationalLevel
References:
Conor O Callahan Supervisor Medtronic 087 2343542
Patrick Carr Supervisor Medtronic 085 1100679
Kevin Murphy Supervisor UCB 087 2253185