Quality Assurance Regulatory Auditor

About the role

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

Responsibilities

• 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
• Evaluates 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
• Aids in preparing for and hosting external customer, regulatory, and registrar audits
• Inspects 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

Qualifications

• 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.

Preferred Qualifications

• 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

Pay

The salary range for this role is $55,000 – $65,000 per year, in addition to our comprehensive benefits package. A candidate's salary is determined by various factors, including but not limited to education, relevant work experience, skills, and certifications. Salary ranges may vary based on geographic location and market conditions.

Benefits

Battelle offers comprehensive and competitive benefits to help you live your best life. These include a compressed work schedule, enhanced work flexibility, paid time off, wellness incentives, and optional supplemental benefits. For more information about our other openings, please visit www.battelle.org/careers.