Quality Assurance Specialist III

Company: Roche
Location: Vacaville
Posted on: August 1, 2022

Job Description:

The PositionQuality oversight and management of Quality System used for change management, corrective and preventive action, support Vacaville activities for development and deployment of global documents (review feedback, impact assessment, and implementation).Experience (may vary depending on site size/scope)Experience in commercial quality or biopharmaceutical environments is preferred.Experience partnering within a team, cross functionally, at the site and within the network is preferred. Experience with managing change control records is required for the Change Control Specialist and/or working as a Technical Writer in an Electronic Document Management System is required for the Quality Document Specialist; experience with Veeva is preferred.Knowledge/Skills/Competencies (base case for roles within the Quality Organization)Follow proper safety precautionsTrain personnel and internal customers on relevant business processes.Maintain state of inspection readinessSupport routine Manufacturing and Quality Control operations and allocate assigned resources to solve complex issuesServe as the Quality representative on cross-functional and multi-site teams.Perform tasks as requested by Management to support Quality oversight activitiesSound knowledge of cGMPs or equivalent regulations and how they apply to Drug Substance.Interpret and relate Quality standards for implementation and reviewAssess potential quality or regulatory issues that may affect product quality or regulatory compliance.Participate in internal audits and regulatory inspections to present Quality records and achieve optimal outcomesTroubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.Sign documents for activities as authorized and described by Genentech policies, procedures and job function on behalf of Vacaville Quality.Knowledge of Genentech 's products and quality pharmaceutical systems is strongly desired.Strong skills in cross-functional and self directed work teamsStrong coordination with complex projectsStrong negotiation, influence, and decision-making skills in order to meet local, network, and global objectives and initiatives.Strong verbal and written communication skills, ability to organize and present information both formally and informally.Strong business acumen in developing, implementing, maintaining, and improving business processes and meeting business, quality, and customer needs in the pharmaceutical/biotechnology industryUnderstanding of Roche Agile methodology, growth mindset, and ability to flow talent to the most important workAll additional and specific work responsibilities will be captured in Workday by the manager.Work Environment/Physical Demands/Safety ConsiderationsStandard office environmentAd-hoc remote work possibleMust be able to work on campus at least 1 day per weekRelocation assistance is not available for this position.Who we areA member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.Diversity and Inclusion (D) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

Keywords: Roche, Vacaville , Quality Assurance Specialist III, Other , Vacaville, California