Regulatory QA Auditor — Hybrid & Impactful Compliance

Battelle; Kentucky; Sur place; USD 55 000 - 65 000; Plein temps

Avantages offerts par ce poste

Hybrid work schedule

Paid time off

Medical, dental, vision coverage

401(k) with company match

Tuition assistance

Résumé du poste

Battelle in Columbus, OH is hiring a Quality Assurance Regulatory Auditor. This full-time role focuses on audits to validate documents, records, and work meet Battelle and FDA standards. You will develop QA plans, advise leadership on risk, and support external regulatory and customer audits.

The position requires a Bachelor’s degree in a related field, 2 years in QA, and the ability to obtain a government security clearance. Periodic travel to West Jefferson, OH is expected.

Qualifications

• Bachelor's degree in a related field and 2 years of quality assurance experience with strong communication skills.
• Demonstrated knowledge of regulatory practices and applicable guidance documents.
• Must be able to obtain a government security clearance upon hire.
• Periodic travel to Battelle's West Jefferson, OH location.
• Authorization to work in the United States; no visa sponsorship available.

Responsabilités

• Develops and executes quality assurance plans, guiding project delivery with metrics and controls.
• Interprets regulatory requirements and industry standards to ensure compliance and audit readiness.
• Audits documents and records to verify compliance with FDA guidance and SOPs.
• Advises Operations on issues observed during inspections to mitigate risk.
• Assists in preparing for and hosting external audits by customers and regulators.
• Reviews project documents for compliance with RFPs, regulations, and SOPs.
• Performs facility and records inspections and issues corrective actions as needed.
• Assesses corrective actions and reports nonconformances to leadership.
• Reviews subcontracted services to ensure proper adherence to procedures.
• Determines whether work meets acceptable standards, including nonroutine tasks.

Connaissances

Communication skills

Regulatory knowledge

Security clearance (upon hire)

Travel to West Jefferson OH

Authorized to work in the US

Formation

Bachelor's degree in related field

2 years QA experience

Description du poste

Battelle in Columbus, OH is hiring a Quality Assurance Regulatory Auditor. This full-time role focuses on audits to validate documents, records, and work meet Battelle and FDA standards. You will develop QA plans, advise leadership on risk, and support external regulatory and customer audits.

The position requires a Bachelor’s degree in a related field, 2 years in QA, and the ability to obtain a government security clearance. Periodic travel to West Jefferson, OH is expected.