Quality Assurance Officer

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 exceeded Responsible for advising the Study Director/Principal Investigator if time required for audit exceeds budget Client accountabilities specific to this position: Interacts and represents MRIGlobal in a professional manner when communicating with staff members, clients, and regulatory agency members Assists in hosting client audits and serves as back up Assists in the preparation or review of Quality Assurance sections of proposals Maintains confidentiality of data Internal Process accountabilities specific to this position: Monitors ongoing laboratory studies for compliance to protocols, QA plans, standard operating procedures, and regulatory requirements Reviews 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 requirements Conducts inspections and audits of facilities, procedures and data to determine compliance with regulatory and MRIGlobal requirements Assists in the preparation of QA plans, protocols, procedures and QAU records Establishes and maintains QA files and records in compliance with applicable regulatory and MRIGlobal requirements May be required to participate in monitoring of controlled substances Other duties as assigned People 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 requested Conducts training sessions for staff on regulatory issues   Success Factors Knowledgeable of a broad range of technical disciplines Proficient oral and written communication skills Able to understand and work in multiple interdisciplinary fields Ability to organize, prioritize and be detail oriented Ability to work independently and in a team environment across organizational lines Ability to wear personal protective equipment during audits Proficient 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 requirements Working knowledge of FDA Class II or III medical device and/or in vitro diagnostic device regulation 510(k) and/or Premarket Approval (PMA) process Experience preparing, filing and completing regulatory submissions 510(k), PMA, Technical Files and other regulatory documentation Experience working with FDA, notified bodies and/or international health authorities Experience with ISO 17025