Quality Assurance Officer

Battelle • Columbus, OH

3d • $85,000 - $100,000 • Hybrid

About The Position

Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency.
We recognize and appreciate the value and contributions of individuals from a wide range of backgrounds and experiences and welcome all qualified individuals to apply.
Job Summary
We are currently seeking a Quality Assurance Officer. This position is a full-time opportunity located in Columbus, OH. In this role, you will assess and review documents and proposals to ensure compliance with Battelle's standards of quality as defined by government regulations, client specifications, and internal policies. You will execute critical inspections, develop corrective action plans, and provide oversight and guidance to junior staff members within the Quality team under Battelle's National Security Division.

Requirements

• 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
• This position requires periodic travel to Battelle's West Jefferson, OH location
• Must be able to obtain and maintain a Secret clearance

Nice To Haves

• ISO 17025 Auditor certification
• ISO 9001 Certified Internal or Lead Auditor
• 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

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
• May serve 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
• Conducts work within prescribed budgets or discusses variances with management prior to executing tasks; may oversee junior staff progress on assigned budgets
• May identify requirements for interested parties and customers and determine gaps between the current QMS and customer or interested party requirements
• May conduct 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
• Assists the Senior QA Officer and/or Manager during inspections performed by clients and/or regulatory agencies
• May develop and process SOPs, advise staff on existing, revised, or new operating procedures, and represent Quality Assurance and/or management on key committees such as the Computer Software Validation Committee and SOP Committee

Benefits

• compressed work schedule that allows for every other Friday off
• hybrid arrangement: 60% in-office and 40% remote
• paid time off
• medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits
• Coverage for partners, gender-affirming care and health support, and family formation support
• industry-leading 401(k) retirement savings plan with employer contribution
• Tuition assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level