Job SummaryActs 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 LifeWe 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 SucceedFor 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
