Senior QA Auditor

Senior Quality Assurance Auditor   Basic Function/Nature and Scope The Senior Quality Assurance Auditor at MRIGlobal provides quality input and oversight to GMP/GLP and/or ISO9001:2015 programs and projects as directed by senior levels of QA staff and/or management. This position assists in auditing programs to ensure compliance with MRIGlobal and applicable regulatory requirements.  Responsibilities and duties are performed independently and require knowledge of applicable regulatory requirements, auditing procedures, and application of corrective and preventive measures as appropriate.   Essential Functions   Audits: Conducts internal audits of documentation, reports and processes for applicable programs and projects and provides required documentation of all associated activities.   Inspections: Periodically inspects laboratory facilities, reports findings, and follows through to ensure all necessary changes occur and compliance requirements are met.   Equipment: Inspects equipment for availability of approved SOPs, maintenance and calibration records.   Compliance: Maintains the QAU reserve sample archive; maintains MRI staff training files and assists with the QAU records.   Document Control: Assists in creating, editing, control and distribution of MRIGlobal SOPs.   Internal and External Communication: Interacts and represents MRI in a professional manner when communicating with staff members, clients and regulatory agency staff members.       Minimum Qualifications Bachelor's degree (B.S./B.A.) in Chemistry, Biology, or related science from a four-year university or college. A minimum of three years directly related experience in science, GxP quality assurance and/or training. Equivalent combination of education and experience. Excellent computer skills including familiarity with Microsoft business applications. U. S. Citizenship is required.     Preferred Qualifications Direct experience in CRO, CDMO, commercial pharmaceutical, medical device, or other relevant GxP QA role. Capability to manage diverse job responsibilities in a fast paced, highly complex organization.