Senior Quality Assurance Officer

Job Summary

Battelle is seeking a Senior Quality Assurance Officer to lead Quality Assurance within our CBRNE business line. Responsibilities include reviewing and determining appropriate corrective actions, facilitating causal analysis, collaborating on research proposals, identifying gaps in quality management system controls, providing quality assurance cost estimates, developing and executing quality assurance plans, mentoring junior staff, conducting validation audits, performing internal facility inspections, and representing Quality Assurance on key committees.

Responsibilities

• Reviews and determines the appropriate corrective action for areas of noncompliance, and either implements these actions or makes recommendations to management for complex issues.
• Facilitates causal analysis to identify root causes, develops action plans, oversees the implementation of corrective and preventive actions, and verifies the effectiveness of these corrective measures.
• Collaborates with management to develop research proposals, ensuring a thorough understanding of interested party requirements and execution risks.
• Identifies gaps in quality management system controls and drives process development and improvement to meet applicable requirements.
• Provides quality assurance cost estimates for planned work.
• Collaborates with management to develop quality assurance policies and procedures to reflect changes in industry or government-related regulations and Battelle policy.
• Develops and executes quality assurance plans, applying appropriate measures, metrics, and management controls with the goal of guiding flawless project execution and delivery.
• Mentors junior quality assurance staff and may develop and conduct quality assurance training programs.
• Maintains comprehensive knowledge of all relevant regulations, as well as current Battelle and department policies.
• In coordination with Quality Management, assigns new studies to auditors, ensuring workloads are balanced and that inspections are completed at their respective sites.
• Conducts work within prescribed budgets or consults with management before proceeding with tasks.
• Oversees junior staff on projects ensuring budgets are met.
• Performs validation audits of equipment and systems, conducts internal facility inspections for compliance with all stated requirements, and completes peer reviews of audits.
• Provides guidance to auditors and conducts routine, non-routine, or focused internal quality assurance audits or inspections as necessary or required.
• Performs or assists management on inspections/audits performed by clients and/or regulatory agencies.
• Reviews subcontracted services on site to ensure experimental procedures are being followed.
• Reviews project operations to confirm adherence to experimental procedures.
• Prepares written reports of audit and inspection findings for management and ensures that appropriate corrective actions are taken.
• May represent Quality Assurance and/or management on key committees such as Computer Software Validation Committee and SOP Committee.

Qualifications

• Bachelor's Degree in a related field; eight (8) years of experience in a quality assurance program applied to laboratory operations, and proven leadership skills; or an equivalent combination of education and/or experience in a related field.
• Experience with ISO 9001, ISO 17025, or other quality standards.
• Must have working knowledge of regulatory practices and other guidance documents.
• Must be a sole U.S. Citizen.

Preferred Qualifications

• Experience participating on committees both internal and external to the organization to provide a quality perspective on continual improvement processes.
• Experience with certification as a Quality Auditor (e.g., ASQ Certified Quality Auditor, ISO 9001:2015 Certified Auditor, etc).