Sr. Quality Assurance Officer

Battelle; Columbus (OH); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Compressed schedule

Hybrid work model

Paid time off

401(k) match

Tuition assistance

Wellness benefits

Job summary

Battelle is seeking a Lead Quality Assurance professional for its CBRNE laboratory division. You will guide QA staff, manage audits, ensure compliance with government regulations, and communicate findings with the Quality Manager.

You will mentor junior staff, develop QA plans, and align procedures with regulatory changes while overseeing budgets and resources for audits and inspections.

Qualifications

• Bachelor's Degree in a related field; 8 years of experience in a quality assurance program applied to laboratory operations including use of analytical equipment.
• Experience with ISO 17025.
• Must have working knowledge of regulatory practices and other guidance documents.
• Must be able to obtain a top secret clearance

Responsibilities

• Lead QA in the CBRNE laboratory, including training and audit management.
• Determine corrective actions for noncompliance, implement actions, and verify effectiveness.
• Develop QA policies and procedures to reflect regulatory changes and Battelle policies.
• Develop and execute QA plans in analytical lab settings with metrics and controls.
• Mentor junior QA staff and conduct QA training programs.

Skills

QA leadership

Regulatory knowledge

Auditing

Root cause analysis

Team mentoring

Education

Bachelor's degree in a related field

Tools

Analytical equipment

Job description

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

Acts as lead for Quality Assurance within our Chemical, Biological, Radiological, Nuclear, and Energetics (CBRNE) laboratory business, including training, audit management, and assignments, and timely communications with Quality Manager. Guides QA staff and determines if the work conducted and the products generated comply with Battelle's standards of quality as defined by Government regulations, client specifications and internal policies.

Responsibilities

• Reviews and determines the appropriate corrective action for areas of noncompliance, and either implements these actions or makes recommendations to management for complex issues that require extensive knowledge and experience. Facilitates causal analysis to identify root causes, develops action plans, oversees the implementation of corrective and preventive actions, and verifies the effectiveness of these corrective measures.
• Collaborates with management to develop research proposals, ensuring a thorough understanding of interested party requirements and execution risks. Identifies gaps in quality management system controls and drives process development and improvement to meet applicable requirements. Provides quality assurance cost estimates for planned work.
• Collaborates with management to develops quality assurance policies and procedures to reflect changes in industry- or government-related regulations and Battelle policy.
• Develops and executes quality assurance plans in an analytical lab setting, applying appropriate measures, metrics, and management controls with the goal of guiding flawless project execution and delivery.
• Provides mentoring to junior quality assurance staff and may develop and conduct quality assurance training programs. Maintains comprehensive knowledge of all relevant regulations, as well as current Battelle and department policies.
• In coordination with Quality management, assigns new studies to auditors, ensuring workloads are balanced and that inspections are completed at their respective sites. Conducts work within prescribed budgets or consults with management before proceeding with tasks. Oversee junior staff on projects ensuring budgets are met. Performs validation audits of equipment and systems, conducts internal facility inspections for compliance with all stated requirements, and completes peer reviews of audits.
• Provides guidance to auditors and conducts routine, non-routine, or focused internal quality assurance audits or inspections as necessary or required. Performs or assists Manager on inspections/audits performed by clients and/or regulatory agencies.
• Reviews subcontracted services on site to ensure experimental procedures are being followed. Reviews project operations to confirm adherence to experimental procedures. Prepares written reports of audit and inspection findings for management and ensures that appropriate corrective actions are taken.

Key Qualifications

• Bachelor's Degree in a related field; 8 years of experience in a quality assurance program applied to laboratory operations including use of analytical equipment, and proven leadership skills
• Experience with ISO 17025
• Must have working knowledge of regulatory practices and other guidance documents.
• Must be able to obtain a top secret clearance

Preferred Qualifications

• Knowledge of Battelle policies and procedures.
• Experience participating on committees both internal and external to the organization to provide a quality perspective on continual improvement processes.
• Certified auditor (i.e. ASQ Certified Quality Auditor, ISO 9001:2015 Certified Auditor, etc).
• Experience supporting 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