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Battelle · 1 month ago

Quality Assurance Regulatory Auditor

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

Battelle is a research and development organization that manages national laboratories and delivers critical services. They are seeking a Quality Assurance Regulatory Auditor to conduct audits and assessments to ensure compliance with standards, regulations, and internal policies, while also providing leadership to the Operations team regarding compliance issues.

Biotechnology

No H1B

Security Clearance Required

Responsibilities

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

Qualification

Regulatory practices knowledgeISO 17025 AuditorISO 9001 Certified AuditorQuality assurance program experienceCausal analysis facilitationQuality tools experienceQuality programs experienceCommunication skills

Required

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

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

Benefits

Balance life through a compressed work schedule: Most of our team follows a flexible, compressed work schedule that allows for every other Friday off—giving you a dedicated day to accomplish things in your personal life without using vacation time.

Enjoy enhanced work flexibility, including a hybrid arrangement: You have options for where and when you work. Our Together with Flexibility model allows you to work 60% in-office and 40% remote, with Monday and Tuesday as common in-office days, dependent on team and position needs.

Take time to recharge: You get paid time off to support work-life balance and keep motivated.

Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.

Better together: Coverage for partners, gender-affirming care and health support, and family formation support.

Build your financial future: Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.

Advance your education: Tuition assistance is available to pursue higher education.