Quality Assurance Regulatory Auditor

Battelle • Columbus, OH

1d • 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 Regulatory Auditor. This position is a full-time opportunity located in Columbus, OH. In this role, you will conduct audits to determine whether documents, records, and work meet and comply with Battelle standards, government regulations, client specifications, and internal policies. You will apply specialized knowledge of assay-specific instrumentation, laboratory techniques, and FDA industry guidance to evaluate complex and highly variable work against nuanced compliance requirements. You will also develop and execute quality assurance plans, advise operational leadership on risk mitigation, and support the organization in preparing for and hosting external regulatory and customer audits.

Requirements

• Bachelor's degree in a related field and 2 years of experience in a quality assurance program with proven communication skills, or an equivalent combination of education and experience in a related field.
• Demonstrated knowledge of regulatory practices and applicable guidance documents.
• Must be able to obtain a government security clearance upon hire.
• This position requires periodic travel to Battelle's West Jefferson, OH location.
• Applicants must have authorization to work in the United States. We are unable to sponsor or take over sponsorship of any employment Visa at this time.

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

• Lead quality assurance activities across laboratory and project environments, ensuring compliance with regulatory and contractual requirements.
• Develops and executes quality assurance plans, applying appropriate measures, metrics, and management controls to guide flawless project execution and delivery.
• Interprets and applies existing and new regulatory requirements and industry standards to operational methods and practices, advising management that work will be compliant and withstand external audit.
• Audits documents, records, and work performed to determine compliance with complex and nuanced requirements, utilizing knowledge of assay-specific instrumentation, laboratory techniques, and current FDA industry guidance.
• Advises and provides leadership to the Operations team regarding issues observed during inspections to mitigate risk.
• Assists in preparing for and hosting external customer, regulatory, and registrar audits.
• Reviews project planning documents — including technical protocols, project plans, and test plans — for compliance with stated requirements such as RFPs, government regulations, and SOPs.
• Performs inspections of Battelle facilities and corresponding documents and records to determine compliance; issues or assesses corrective actions based on observations.
• Assesses the sufficiency of corrective actions or allowable deviations and reports work nonconformances and audit findings to project leadership and management.
• Reviews subcontracted services on-site to ensure experimental procedures are being followed.
• Determines whether work meets acceptable standards, with a focus on nonroutine and highly variable work.

Benefits

• Compressed work schedule (every other Friday off)
• Hybrid work arrangement (60% in-office, 40% remote)
• Paid time off
• Medical coverage
• Dental coverage
• Vision coverage
• Wellness incentives and benefits
• Optional supplemental benefits
• Coverage for partners
• Gender-affirming care and health support
• Family formation support
• 401(k) retirement savings plan (5% employer contribution regardless of employee contribution, plus matching)
• Tuition assistance

What This Job Offers

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