Quality Assurance Officer Basic Function Conducts facility audits and audits in selected areas for compliance with federal agency regulations, ISO standards or as required by client. Conducts audits at subcontractor’s facilities to assure compliance with client requirements. Maintains documentation as required by regulatory guidelines and MRIGlobal procedures. Assists the Quality Assurance Officers or others as directed by management in diverse areas of the MRIGlobal QA program. Assists in hosting client audits. Nature and Scope This position reports to the Director of Quality & Regulatory Systems and is responsible for conducting audits of selected studies and facilities for compliance with regulations, standards, and MRIGlobal procedures. Assures that observations are documented and submitted to the appropriate Study Director/Principal Investigator and to Management. Reviews responses to assure that appropriate action has been taken to bring the study into compliance. Provides technical expertise on identifying actions to resolve compliance problems. In addition, this position may provide QA support to other MRIGlobal facilities in general or follow up audits and conduct audits at subcontractor facilities to determine quality compliance to meet contractual requirements by clients. Principal Accountabilities Financial accountabilities specific to this position:Responsible for monitoring expenses to ensure budgetary limits are not exceededResponsible for advising the Study Director/Principal Investigator if time required for audit exceeds budgetClient accountabilities specific to this position:Interacts and represents MRIGlobal in a professional manner when communicating with staff members, clients, and regulatory agency membersAssists in hosting client audits and serves as back upAssists in the preparation or review of Quality Assurance sections of proposalsMaintains confidentiality of dataInternal Process accountabilities specific to this position:Monitors ongoing laboratory studies for compliance to protocols, QA plans, standard operating procedures, and regulatory requirementsReviews and audits study reports to ensure that reports are complete, accurate, and fully supported by the raw data in the study file and in compliance with applicable regulatory requirementsConducts inspections and audits of facilities, procedures and data to determine compliance with regulatory and MRIGlobal requirementsAssists in the preparation of QA plans, protocols, procedures and QAU recordsEstablishes and maintains QA files and records in compliance with applicable regulatory and MRIGlobal requirementsMay be required to participate in monitoring of controlled substancesOther duties as assignedPeople accountabilities specific to this position:Communicates clearly both orally and in writing observations of violations of regulatory requirements in audit reports Counsels Study Directors/ Principal Investigators and staff members on regulatory issues. Proposes appropriate action if requestedConducts training sessions for staff on regulatory issues Success Factors Knowledgeable of a broad range of technical disciplinesProficient oral and written communication skillsAble to understand and work in multiple interdisciplinary fieldsAbility to organize, prioritize and be detail orientedAbility to work independently and in a team environment across organizational linesAbility to wear personal protective equipment during auditsProficient in operating computers and ability to learn new software Minimum Qualifications BA/BS degree in chemistry, biology or related science, at least two years of laboratory experience and two years of quality assurance experience. Applicants selected will be subject to a government security investigation and must meet eligibility requirements. In order to meet the government security investigation requirements, U.S. citizenship is a prerequisite. Preferred Experience with CLIA/CAP accreditation and regulatory requirementsWorking knowledge of FDA Class II or III medical device and/or in vitro diagnostic device regulation 510(k) and/or Premarket Approval (PMA) processExperience preparing, filing and completing regulatory submissions 510(k), PMA, Technical Files and other regulatory documentationExperience working with FDA, notified bodies and/or international health authoritiesExperience with ISO 17025