Columbus, OH, 43201, USA
4 days ago
Quality Assurance Officer
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 with diverse backgrounds and experiences and welcome all qualified individuals to apply. **Job Summary** Battelle is seeking a **Quality Assurance Officer** to provide oversight and support of animal welfare in Life Sciences Research (LSR). The work is conducted in accordance with Good Laboratory Practice (GLP) regulations as applicable, and LSR is ISO 9001:2015 certified. The Quality Assurance Officer 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** + Determines appropriate corrective action for areas of noncompliance and makes recommendation to management. May facilitate causal analysis, development of action plans, implementation of corrective/preventive actions, and verification of effectiveness of corrective actions. + May identify requirements for interested parties and/or customers and determine gaps between current QMS and customer or interested party requirements. + In collaboration with the Sr QA Officer and/or QA manager, reviews research proposals to assess quality assurance requirements to determine that regulatory requirements are adequately addressed and that QA-related cost estimates are correct. + May develop and conduct quality assurance and/or animal welfare training programs. Maintains a thorough knowledge of all QA regulations, current Battelle and department policies. + Conduct work within prescribed budget or discuss with management prior to conducting task. May oversee junior staff progress on assigned budgets. Performs validation audits of equipment and systems. Performs internal facility inspections for compliance to all stated requirements. May perform peer reviews of facility inspections. + May conduct routine or focused internal QA audits or inspections as necessary or required. Reviews subcontracted services on site to ensure experimental procedures are being followed. Reviews project operations to ensure experimental procedures are being followed. + May serve as QA project officer or QA program manager for specific interested parties’ requirement, internal or external R&D projects, and/or task order contracts requiring such position. + Reviews project planning documents (technical protocols, test plans, software development plans, systems engineering plans, manufacturing plans, etc.) for compliance with applicable stated requirements. Schedules and performs critical phase inspections to ensure compliance with stated requirements. Oversees junior auditors who may perform critical phase audits on the projects that they lead. Audits records and reports for compliance to stated requirements. Oversees junior auditors who may perform critical phase audits on the projects that they lead. Prepares written reports of audits and inspection findings for management and ensures appropriate corrective action is taken. + May develop and process SOPs and advise staff of existing, revised or new operating procedures. May represent Quality Assurance and/or management on key committees such as Institutional Animal Care and Use Committee (IACUC), Computer Software Validation Committee, and SOP Committee. + Assists Sr. QA Officer and/or Manager on inspections performed by clients and/or regulatory agencies. **Key Qualifications** + Bachelor's Degree in a related field; 6 years of experience in a quality-related program and/or an animal-related program and proven communication skills; or an equivalent combination of education and/or experience in a related field. + Certified by a professional quality organization, e.g., Registered Quality Assurance Professional in the Good Laboratory Practices, ISO or other applicable areas. Will accept animal-related certification, e.g., Laboratory Animal Technician (LAT) in lieu of quality certification. + Must have appropriate knowledge of regulatory practices and other guidance documents. + Must have served at least one term on an IACUC. + Must be a US citizen to perform duties of this role. + Must be willing to be immunized with licensed and FDA-approved vaccines and medications recommended for persons at risk of occupational exposure to biological or chemical agents. **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. **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 + Collaborate with world-class experts in an inclusive 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
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