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Quality Technician/Deputy

Location: irvine
Posted on: May 3, 2021

Job Description:

Job DetailsLevelUndisclosedJob LocationABC Testing - Irvine, CARemote TypeN/APosition TypeUndisclosedEducation LevelUndisclosedSalary RangeUndisclosedTravel PercentageUndisclosedJob ShiftUndisclosedJob CategoryUndisclosedQuality Technician/Deputy Level IIPosition Summary:The purpose of this position is to assist the Quality Assurance Manager and supervise all personnel to ensure regulatory compliance.Responsibilities:The essential functions of the position include, but are not limited to:Assist QA Manager in the drafting, planning, and implementation of all quality programs, projects, process and/or activities to ensure quality products/services are regulatory compliant;Supervise personnel to ensure that all manufacturing activities are consistent with corporate and facility policies, procedures, and programs.Assist the Quality Assurance Manager for adherence to all laboratory procedures and policies, while performing oversight functions and reviews of laboratory operations. Manage or assist with the management of the equipment qualification, calibration and maintenance program.Ensure facility compliance with current Good Manufacturing Practice (cGMP) and any other applicable federal and international regulatory requirements.Generate, issue, train and manage Quality System procedures, test methods, and protocols.Review and approve laboratory procedures, protocols and other technical documents.Review laboratory test resultsGenerate and issue nonconformances, OOS investigations and deviationsTrack, monitor, document, and review all process and procedural changes through the change control system, deviations, and out of specification investigations. Develop and implement governed corrective and preventative actions (CAPA). Complete required questionnaires from customers as needed.Assist with the approval and monitoring of all suppliers and contract (third party) vendor activities. Conduct internal audits in conjunction with management.Assist in client and internal facility audits.Assist with Federal (FDA and OSHA), State, local, and third party audits.Participate in Management Review Meetings.Quality Technician/Deputy Level IIRequirements:The minimum education and background experience needed for this position are:BA/BS degree, major in Chemistry related field preferred.Laboratory experience of 2+ years.Strong understanding cGMP GLP GDP.Experience in writing Quality related procedures, protocols, and manuals.Proficiency in Microsoft Word and Excel.Analytical and organizational skills.Strong communication skills.Demonstration of supervisory skills and leadership ability.

Keywords: CERTIFIED LABORATORIES GROUP, Irvine , Quality Technician/Deputy, Other , irvine, California

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