Quality Assurance Auditor

3,790.00 - 4,740.00 USD /month Status:   Full Time, Employee Job Category:   Quality Assurance/Safety Company:   Battelle Reference Code:   BT15467 Quality Assurance Auditor Battelle is a world leader in science and technology contract research. Our Biomedical Science and Technology Product Line specializes in the development and application of innovative solutions to critical issues in biosciences in the areas of national security, human health and safety, environmental protection, and agriculture. Some travel may be required. Compensation will be based on qualifications and experience. Relocation support is not available. PRIMARY FUNCTION Assure that programs are conducted in compliance with all applicable regulations/standards (such as Good Laboratory Practices, Good Manufacturing Practices) and quality assurance plans of government agencies and Battelle policies by performing data audits and inspections. May provide assistance and training to others. MAJOR RESPONSIBILITIES 1. Reviews protocols for GLP or applicable regulatory compliance/SOP compliance/consistency. Attends study meetings with key staff. Schedules critical phase inspections with all levels of study staff. 2. Performs critical phase inspections, which include monitoring for appropriate regulatory/guidance, protocol, and SOP compliance. Reports findings to study director and/or management. 3. Audits entire study files for appropriate regulatory/guidance, protocol, and SOP compliance; this includes reporting all findings to the study director and/or management, resolving all items with study team, and bringing major issues to the entire unit, program management and resource management. 4. Audits final reports for compliance with GLP or other appropriate regulatory/guidance document, and protocol, SOP, etc. requirements. This includes reviewing the entire report for accuracy and verification against raw data and study files, reporting findings to the study director and/or management and signing a QA statement for each report, if applicable. 5. Performs internal Quality audits. May coordinate client and regulatory audits and inspections, and participate in the audits and prepare response reports. 6. May prepare cost projections for studies. Monitors budget through the course of the study, managing time accordingly and documenting overruns and notifying program management. 7. Performs internal facility inspections of all labs and supporting areas to assess regulatory compliance or other appropriate guidance compliance and reports findings to management. 8. May perform subcontractor facility inspections, including scheduling travel and inspection meetings and representing Battelle during visits. 9. Maintains Quality Assurance databases. Reviews validation packages and systems for compliance to SOPs. 10. Reviews SOPs, methods and forms. The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of staff members so classified. JOB REQUIREMENTS Requires a Bachelor's Degree or equivalent experience in a relevant field, and a minimum of two years of quality auditing experience in a regulatory GLP and/or GMP environment. Proven experience as a thorough reviewer is required. Candidates with experience and working knowledge of GLP regulations in a non-clinical laboratory facility are preferred. Must be willing to be immunized with licensed and FDA approved Investigational New Drugs (IND). Selected applicant will be subject to a government security investigation and must meet eligibility requirements, including U.S. citizenship, to obtain a Department of Justice clearance within one year of employment and be subject to periodic drug testing.