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Battelle Memorial Institute Quality Assurance Officer in Columbus, Ohio

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.

Battelle is seeking an Quality Assurane Officer . The position is located in Columbus, OH .

JOB SUMMARY

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.

MAJOR 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 training programs. Maintains a thorough knowledge of all QA requirements, 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 internal facility inspections for compliance to all stated requirements.

  • 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 processes SOPs and advises staff of existing, revised or new operating procedures. May represent Quality Assurance and/or management on key committees such as Computer Software Validation Committee and SOP Committee.

  • Manages/supports inspections performed by clients and/or regulatory agencies.

THE FOLLOWING IS REQUIRED

  • 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 or Math or equivalent experience.

  • Requires a minimum of 5 years of experience in a quality assurance program and proven communication skills.

  • Required to be certified in ISO 9001:2015 (Internal and/or Lead Auditor), with additional ISO 17025 experience/certification preferred.

  • Must have appropriate knowledge of regulatory practices and other guidance documents.

  • Knowledge of Battelle policies and procedures is preferred.

  • Must Be US Citizen.

THE FOLLOWING IS DESIRED

• 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.

LEGAL DISCLAIMER

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.

BENEFITS

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.

As a condition of employment, Battelle will inquire about COVID vaccination status, and in the event that vaccinations are mandated at a work location (including client site and Battelle sites) we expect all candidates to comply with these required safety protocols.

Battelle is an affirmative action and equal opportunity employer. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact recruiting@battelle.org .

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 or expression, 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

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