Battelle Memorial Institute C5805 - Senior Quality Assurance Officer - TEST in West Jefferson, Ohio
Battelle is guided by a founding mission. We invest our knowledge, talents and resources, helping our customers achieve their most important goals. We apply scientific rigor and creativity, succeeding where others may fail, and we invest in our communities, making the world better for generations to come. All of us share a common purpose: to solve the greatest challenges of today and tomorrow.
Our 22,000 employees work at the forefront of scientific innovation to tackle critical challenges in security, human health, manufacturing, energy and environmental management. Battelle’s work is grounded in the belief that science, technology and a passion for excellence can make industries more competitive and the world a better place.
Acts as lead for Quality Assurance, including training, scheduling audits 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.
Reviews and determines appropriate corrective action for areas of noncompliance and implements or makes recommendation to management for complex problems requiring extensive knowledge and experience. Facilitates causal analysis, development of action plans, implementation of corrective/preventive actions, and verification of effectiveness of corrective actions.
Identifies requirements for interested parties and/or customers and determine gaps between current QMS and customer or interested party requirements. Works with the team and drives process development and improvement to meet requirements.
In collaboration with management reviews research proposals to assess quality assurance requirements to determine that regulatory requirements are adequately addressed and that QA-related cost estimates are correct. Develops Quality Assurance Project Plans for projects as required. Writes Quality Assurance Plans (QAP) or provided QA input on proposals as requested.
Ensures new staff in respective facility receive training and ensure QA staff are trained on all applicable requirements. Provide mentoring to junior quality assurance staff. May develop and conduct quality assurance training programs. Maintains a thorough knowledge of all QA regulations, current Battelle and department policies.
In coordination with Quality management, assign new studies to auditors ensuring the workloads are manageable and inspections are completed at their respective site. Conduct work within prescribed budget or discuss with management prior to conducting task. Oversee junior staff on projects which you are the lead to ensure budgets are met. Performs validation audits of equipment and systems. Performs internal facility inspections for compliance to all stated requirements. Performs peer reviews of audits.
Provides guidance to auditors and conducts routine, non-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. Prepares written reports of audits and inspection findings for management and ensures appropriate corrective action is taken.
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.
Provides guidance to auditors and 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 represent Quality Assurance and/or management on key committees such as Computer Software Validation Committee and SOP Committee. In collaboration with management, develops quality assurance policies and procedures to reflect changes in industry- or government-related regulations and Battelle policy. Maintains SOP manuals at the facility. Ensures SOPs are updated and accurate. Develops and processes SOPs and advises staff of existing, revised or new operating procedures.
Performs or assists Manager on inspections performed by clients and/or regulatory agencies.
May actively participate in committees both internal and external to the organization to provide a quality perspective on continual improvement processes.
Requires a Bachelor's Degree in Science, with emphasis in Biology, Chemistry, Engineering, Physics and Math or equivalent experience.
Requires a minimum of 8 years of experience in a quality assurance program and proven leadership skills.
Required to be certified in a professional quality organization, i.e. Registered Quality Assurance Professional in the Good Laboratory Practices, Good Manufacturing Practices, ISO or other applicable areas.
Must have working knowledge of regulatory practices and other guidance documents.
Must be a U.S. Citizen with ability to obtain and maintain a DoD Secret Security Clearance.
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.
Battelle’s competitive benefits program includes comprehensive medical and dental care, matching 401K, paid time off, flexible spending accounts, disability coverage, and other benefits that help provide financial protection for you and your family.
Battelle provides 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, marital status, age, genetic information, disability, veteran-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.
For more information about our other openings, please visit www.battelle.org/careers