Quality Assurance Expert

Hello,My name is Jothi, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Quality Assurance Expert for a prominent client of ours. This position is located in Rocklin, CA. If you are interested in hearing more about the position please respond to this posting with your resume attached or contact me at 813-444-6306 / jothi.kumari@thefountaingroup.comPlease forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.JOB DESCRIPTION:Title: Quality Assurance ExpertLocation: Rocklin, CADuration: 6+ MonthsHourly Rate on W2: $27.00Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting.The Associate Quality Systems Specialist provides quality support of the site quality management system, ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the Quality Manual focusing on future products, current products, and process improvements. Representing Quality on cross-functional teams to support business needs driving a positive site quality culture may be required.Prepare Quality System documents and reports as needed for Rocklin site metrics and management reviewFollow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality ManualPerforms project review and audit of Device History Files (DHF's)Performs review of data and records supporting the DHF while assessing for good documentation and recordkeeping practices ensuring appropriate requirements are met.Obtains information for clarification from process owners while providing appropriate and relevant feedbackCoordinates files upon completion of review for upload into EDMS as necessaryElectronically signs as technical approver for quality on applicable documents and within the validated electronic databases.Maintain cGMP compliance in the laboratoryWrite, revise, and/or review Standard Operating ProceduresMaintain extensive knowledge of Standard Operating Procedures and GMP regulations and policiesSupport internal and external audits as neededResponds promptly to customer needs; solicits customer feedback to improve service; meets commitments.Understand and follow the requirements of the quality systemMaintain current training requirementsTrains other staff members as requestedAdhere to regulatory requirements (including cGMP), standards, procedures, and company policiesRecommend, provide, or initiate solutions by actively providing suggestions for improvementCollaborate and coordinate with internal stakeholders to identify, escalate, and resolve quality issuesUnderstand, support, and communicate Company mission, vision, and valuesOther duties as assigned or required to support the businessMust be willing and able to work on weekends or extended hours as needed