Quality Assurance Regulatory Auditor

Battelle•Columbus, OH

2d•$55,000 - $65,000•Hybrid

About The Position

Battelle is seeking a Quality Assurance Regulatory Auditor to conduct audits to ensure documents, records, and work comply with Battelle standards, government regulations, client specifications, and internal policies. This role requires specialized knowledge of assay-specific instrumentation, laboratory techniques, and FDA industry guidance to evaluate complex work against compliance requirements. The position also involves developing quality assurance plans, advising on risk mitigation, and supporting external audits. This is a full-time opportunity located in Columbus, OH.

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
Authorization to work in the United States

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

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