Battelle Memorial Institute Quality Assurance Auditor in Columbus, Ohio
Battelle is guided by a founding mission. We invest our knowledge, talents and resources, helping our customers achieve their most important goals. We apply scientific rigor and creativity, succeeding where others may fail and we invest in our communities, making the world better for generations to come. All of us share a common purpose: to solve the greatest challenges of today and tomorrow.
Our 22,000 employees work at the forefront of scientific innovation to tackle critical challenges in security, human health, manufacturing, energy and environmental management. Battelle’s work is grounded in the belief that science, technology and a passion for excellence can make industries more competitive and the world a better place.
We are currently seeking a Quality Assurance Auditor. This position is located in Columbus, OH.
The Quality Assurance Auditor’s primary function is to assure that programs are conducted in compliance with all applicable regulations/standards and quality assurance plans of government agencies and Battelle policies by performing data audits and inspections. May provide assistance to others.
Reviews protocols for GLP, or applicable compliance, and SOP compliance/consistency.
Schedules and performs critical phase inspections to ensure compliance with all levels of study staff.
Performs facility inspections, critical phase inspections and data/report audits, which include monitoring for appropriate regulatory compliance, protocol and SOP compliance and reports findings to the appropriate staff and management; verifies actions are implemented and effective.
Monitors budget through the course of the study and manages time accordingly.
Audits records and reports for compliance to stated requirements.
Participates in continual process improvement activities for the project and the organization.
May provide backup coverage for other QA functions.
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
Bachelor's Degree in a biological science, chemistry or equivalent and a minimum of 2 years of applicable laboratory experience.
Experience auditing regulated projects/documents.
Must be a US citizen.
Ability to obtain/maintain certification in Chemical Personnel Reliability Program (NACLC required) and/or Biological Personnel Reliability Program
Ability to obtain/maintain a DoD security clearance.
Ability to obtain/maintain a CDC security clearance.
Ability to obtain/maintain DoJ Security Risk Assessment (SRA) approval.
Must be willing to work in a biosafety level 2 (BSL2) and/or 3 (BSL3) environment and able to wear appropriate respiratory protection.
Must be willing to be immunized with licensed and FDA approved Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.
Must be willing to participate in periodic drug screening.
Newly hired employees are subject to a 90 day introductory period, during which their performance is evaluated by supervision.
THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:
- Experience with regulatory or other appropriate guidance documents, i.e. GLP regulations
Battelle’s competitive benefits program includes comprehensive medical and dental care, matching 401K, paid time off, flexible spending accounts, disability coverage, and other benefits that help provide financial protection for you and your family.
Battelle provides employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, marital status, age, genetic information, or disability. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.
For more information about our other openings, please visit www.battelle.org/careers