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

Conducts audits/assessments/inspections to determine if documents, records, process, and activities meet and/or comply with Battelle standards, government regulations, client specifications and internal policies. May facilitate causal analysis to identify causes of nonconformances.

KEY QUALIFICATIONS

• Bachelor’s Degree in a related field; 2 years of experience in a quality assurance program and proven communication skills; or an equivalent combination of education and/or experience in a related field.
• Must be able to obtain a government security clearance upon hire.
• Must have appropriate knowledge of regulatory practices and other guidance documents.

PREFERRED QUALIFICATIONS

• ISO 17025 Auditor
• ISO 9001 Certified Internal/Lead Auditor
• Experience facilitating or participating in causal analysis using Quality Tools
• Experience in a variety of Quality Programs

• Audits documents, records, and work being performed to determine compliance to complex and nuanced requirements utilizing knowledge of assay-specific instrumentation and equipment, laboratory techniques, and current industry guidance.
• Determines if work meets acceptable standards. Work being audited is nonroutine and highly variable in nature.
• Performs inspections of Battelle facilities and corresponding documents/records to determine compliance to requirements. Issues or assesses corrective actions based on observation.
• Advises and provides leadership to the Operations team regarding issues observed during inspections to mitigate risk.
• Reviews project planning documents (technical protocols, project plans, test plans, etc.) for compliance with stated requirements (RFPs, Government Regulations, SOPs).
• Assesses the resultant actions and judges the sufficiency of corrective actions or allowable deviations upon the work. Reports work nonconformances and audit findings to project leadership and management.
• Reviews subcontracted services on site to ensure experimental procedures are being followed.
• Interprets and applies existing and new regulatory requirements and industry standards to operation methods and practices. Reviews planned work and advises management and project teams that work will be compliant and will withstand external audit.
• Develops and executes quality assurance plans, applying appropriate measures, metrics, and management controls with intent to guide flawless project execution and delivery.
• Assists in the preparation for and assists in hosting external customer, regulatory, registrar audits.