Quality Assurance Auditor

Battelle is seeking a Quality Assurance Auditor to provide oversight and support of specialized, analytical chemistry laboratories. Participate in the development of processes that meet all applicable stated requirements and customer deliverables.  Assure that tasks are conducted in compliance with all applicable stated requirements (such as Good Laboratory Practices, Good Manufacturing Practices, ISO, Quality Assurance Plans, customer and facility SOPs/Work Instructions/Work plans) and Battelle policies by performing audits and inspections. May provide assistance and training to others.

• Reviews project planning documents (technical protocols, test plans, software development plans, systems engineering plans, manufacturing plans, etc.) for compliance with applicable stated requirements. Attends study meetings with key staff.
• Schedules and performs critical phase inspections to ensure compliance with stated requirements. May have the authority to stop work and notify project/line management if a critical problem arises. Reports findings to appropriate project and line management.
• Audits records and reports for compliance to stated requirements. Reports findings to appropriate project and line management; verifies actions are implemented and effective; participates in continual process improvement activities for the project and the organization.
• Plans, coordinates, and participates in on-site audits from external sources.
• May provide input to proposals including cost projections. Maintains and adheres to project budgets.
• Performs internal facility inspections for compliance to all stated requirements. Reports findings to appropriate project and line management.
• May maintain databases.
• May represent QA and/or management on key committees such as Computer Software Validation Committee and SOP Committee.
• May provide backup coverage for other QA functions.
• Act as mentor to other staff members on Quality Assurance issues.

• Bachelor’s Degree in a science-related field (chemistry emphasis preferred); 2 years of applicable technical experience; or an equivalent combination of education and or experience in a related field.
• Experience with ISO 9001 and/or ISO 17025 standards or other quality system. 
• Must be a US citizen with the ability to obtain and maintain a government security clearance.

• Critical thinking and experience with risk identification. 
• Experience in causal analysis; experience developing processes and controls for processes; experience in reviewing processes and controls to provide input to continual improvement. 
• Ability to inspire and guide staff.

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, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.