Vacancy expired!
Validation CoordinatorLocation:US - GA - AtlantaDepartment:Facility - QADescriptionRequisition Number: 1873JOB SUMMARY:Reporting to the Quality Assurance (QA) Manager, the Validation Coordinator acting as the facility technical representative is responsible for ensuring the requirements for ISO and QSRs are met and maintained for the facility and its customers. The Validation Coordinator provides management with information and data on all key aspects of each customer's validation project, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Engineering and other Sterigenics' facilities, as well as customers and regulatory personnel.DUTIES AND RESPONSIBILITIES:Plans, organizes and coordinates customer validation activities at the facilityWrites validation protocols and final reports supplied by the facilityReviews and approves customer or consultant supplied validation or test protocols for excitability within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standardsResponsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:Scheduling the project runs, ancillary resources, lab testing and sample handlingCycle programming and preparation of necessary process documents and safety assessmentsMicrobiological samplesData collection and analysisAssuring proper handling, storage and shipping of bioburden, LAL biological indicators engineering, or residual samples to the appropriate laboratoryAssures that all validation calibration activities are performed according to Sterigenics QSR and traceable to NISTProvides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipmentProvides on-going training to the plant on validation issuesMaintains the quality and integrity of information required for validation recordsLiaison for all plant and customer activities responding to customers' inquiries whether directly or through Quality Assurance, Customer Service Unit or Sales, to ensure prompt and accurate communication related to technical and validation issuesPerforms other duties as required to support the overall plant operation and quality systemEDUCATION, EXPERIENCE & SKILL REQUIRED:Minimum BA or BS in a science related fieldTwo (2) to three (3) years' experience in the pharmaceutical, food or medical device industryDirect experience in sterility assurance or products sterilization a plusMust have experience in writing and executing validation protocolsISO 9000 experience a plusExcellent written and verbal communication skillsStrong computer skillsSPECIAL REQUIREMENTS:Must possess a thorough understanding of US FDA Quality Systems Regulations and ISO 9000 regulationsUnderstanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirableKnowledge and experience working with the US and International requirements for medical devices is essentialKnowledge of regulatory affairs for a FDA registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA or supplier auditsExperience with a company using EO sterilization of products is desirableExperience in document control to satisfy all ISO 9000 and FDA Quality System requirementsMust be medically approved for respirator use (EO)Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes) (EO)TRAINING REQUIRED: Must complete all required training for For full info follow application link.EOE. Minorities/Women/Protected Veterans/Individuals with Disabilities
Vacancy expired!