Quality Assurance Regulatory Auditor (75641) at Battelle
Battelle · Columbus, United States Of America · Hybrid
- Professional
- Office in Columbus
Career Opportunities: Quality Assurance Regulatory Auditor (75641)
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.
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.
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
Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.
- 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.
A Work Environment Where You Succeed
For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.
You will have the opportunity to thrive in a culture that inspires you to:
- Apply your talent to challenging and meaningful projects
- Receive select funding to pursue ideas in scientific and technological discovery
- Partner with world-class experts in a collaborative environment
- Nurture and develop the next generation of scientific leaders
- Give back to and improve our communities
Vaccinations & Safety Protocols
Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws).
Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.
The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.
For more information about our other openings, please visit www.battelle.org/careers
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.
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.
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
Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.
- 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.
A Work Environment Where You Succeed
For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.
You will have the opportunity to thrive in a culture that inspires you to:
- Apply your talent to challenging and meaningful projects
- Receive select funding to pursue ideas in scientific and technological discovery
- Partner with world-class experts in a collaborative environment
- Nurture and develop the next generation of scientific leaders
- Give back to and improve our communities
Vaccinations & Safety Protocols
Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws).
Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.
The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.
For more information about our other openings, please visit www.battelle.org/careers
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.
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.
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
Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.
- 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.
A Work Environment Where You Succeed
For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.
You will have the opportunity to thrive in a culture that inspires you to:
- Apply your talent to challenging and meaningful projects
- Receive select funding to pursue ideas in scientific and technological discovery
- Partner with world-class experts in a collaborative environment
- Nurture and develop the next generation of scientific leaders
- Give back to and improve our communities
Vaccinations & Safety Protocols
Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws).
Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.
The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.
For more information about our other openings, please visit www.battelle.org/careers
