Quality Assurance Officer

About the role

We are currently seeking a Quality Assurance Officer. This position is a full-time opportunity located in Columbus, OH.

Responsibilities

• Determines appropriate corrective action for areas of noncompliance and makes recommendations to management;
• may facilitate causal analysis, development of action plans, implementation of corrective and preventive actions, and verification of corrective action effectiveness;
• Serves as QA project officer or QA program manager for specific interested party requirements, internal or external R&D projects, and/or task order contracts requiring such a position;
• Reviews project planning documents — including technical protocols, test plans, software development plans, systems engineering plans, and manufacturing plans — for compliance with applicable stated requirements;
• Schedules and performs critical phase inspections to ensure compliance with stated requirements; oversees junior auditors performing critical phase audits on assigned projects;
• In collaboration with the Senior QA Officer and/or QA Manager, reviews research proposals to assess quality assurance requirements, ensuring regulatory requirements are adequately addressed and QA-related cost estimates are accurate;
• Performs validation audits of equipment and systems; conducts internal facility inspections for compliance with all stated requirements; may perform peer reviews of facility inspections;
• Audits records and reports for compliance with stated requirements; prepares written audit and inspection findings reports for management and ensures appropriate corrective action is taken;
• Develops and processes SOPs, advises staff on existing, revised, or new operating procedures, and represents Quality Assurance and/or management on key committees such as the Computer Software Validation Committee and SOP Committee;
• Identifies requirements for interested parties and customers and determines gaps between the current QMS and customer or interested party requirements;
• Conducts routine or focused internal QA audits or inspections as necessary; reviews subcontracted services and project operations on-site to ensure experimental procedures are being followed;
• Affords assistance to the Senior QA Officer and/or Manager during inspections performed by clients and/or regulatory agencies;
• Assists in developing and implementing quality assurance strategies and initiatives.

Qualifications

• Bachelor's degree in a related field and 6 years of experience in a quality assurance program with proven communication skills, or an equivalent combination of education and experience in a related field;
• Certification by a professional quality organization, such as Registered Quality Assurance Professional in Good Laboratory Practices, Good Manufacturing Practices, ISO, or other applicable areas;
• Demonstrated knowledge of regulatory practices and applicable guidance documents;
• Experience facilitating or participating in causal analysis using quality tools;
• Experience in a variety of quality programs;
• Knowledge of Battelle policies and procedures;
• Experience participating on committees to provide a quality perspective on continual improvement processes.

Benefits

Battelle offers a comprehensive benefits package, including:

• Flexible work schedules;
• Hybrid work arrangements;
• Paid time off;
• Wellness programs;
• Tuition assistance;
• Retirement savings plans.