Vacancy expired!
The Senior Quality Engineer - Toxicology Testing position is responsible for oversight of technical quality assurance primarily focused on ensuring that all aspects including facility, equipment test methods, processes and software - and subsequent changes to them - are validated in compliance with applicable regulations, standards, policies, and procedures. This role works closely with all departments especially the Toxicology Laboratory Operations and IT teams to develop and maintain the site's validated status and helps to build a fit-for-purpose Quality Management System that supports the business. This position will play an important role in the coordination of validation projects including QMS optimization. The Senior Quality Engineer will work with the site on non-conformance and CAPA investigations and is expected to perform their duties with a high degree of independence, reporting to quality and site leadership on status of the validation program and risks. Title: Senior Quality Engineer - Toxicology Location: Santa Rosa Contract Terms: Permanent Start Date: 2/15 Specific day to day responsibilities:
Oversee and manage the Laboratory Validation Master Plan and maintain the facility in a validated state Lead teams in root cause analysis of laboratory quality issues and apply appropriate tools (e.g. statistics, fault tree analysis, etc.) to develop corrective action plans Develop and report on quality metrics in order to present them at quarterly management review meetings Top 3 Requirements: Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Sciences or a related discipline, or the equivalent combination of education and experience 3 or more years of experience in a regulated environment such as a laboratory or medical device facility Experience contributing to or managing validation projects from the point of inception to completion, including those that require multiple skills Bonus Points for: Experience with root cause analysis and/or failure mode analysis Experience with statistical tools including basic statistical inference, graphical methods, regression, Design of Experiment, or development of sampling plans Project management or coordination in a healthcare or laboratory environment EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . Vacancy expired!
