Quality Assurance Specialist

Title: QA Validation Specialist 3
Location: 101 International Drive,Portsmouth, NH -03801
Contract: 6+ Months - possibility for extension or FTE conversion
Pay Rate: $90/hr+ Benefits.

JOB DESCRIPTION:
Role is Equipment validation and Cleaning Validation
Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly Drafting SOPs
Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient).
Looking for the worker to Build Equipment Requalifications in Kneat.
Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.
Drive/own the validation plans and execution of equipment changes and process improvements.
Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
PerformEquipmentValidationactivitiestoincludeValidation. MaintenanceQualitySystemsreviewandrequalificationtoensureGMP equipmentiscontinuouslymaintainedinavalidatedstate.
Program,organize,andmaintainValidationequipmentandsuppliesincludingdataloggersandprobes.
Demonstrateageneralunderstandingofbiopharmaceutical manufacturingequipmentandvalidationproceduresforInstallationVerification(IV/IQ),Clean-In-Place (CIP),Steam-In-Place(SIP),Autoclaves,CleanUtilities,ShippingValidation,TemperatureMappingControlledStorageRooms andEquipment.
Developvalidationprotocolsfromplansandengineeringdocuments.
ProvidebasictechnicalsupportwhenreviewingandapprovingSOPs,Protocols,ChangeControls,Deviations,CAPA,etc.
PerformassignedQualitySystemsactivitieswithinDocumentManagementSystem(DMS),TrackWiseQualitySystem(ChangeControl, Deviation,CAPA).
Perform other duties as assigned.


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