Senior QA Specialist
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
This position will primarily be responsible for Supplier Qualification and Management, External and Internal Audits, as well as inspection support. Additionally, this position will support other Quality Systems processes such as Document Control, Quality Records Management, Training, and Quality Event Management (Deviation, CAPA, Change Control), Quality Management Review and maintenance of the electronic Quality Management System (eQMS).
- Manage the Dynavax Supplier Management Program, including but not limited to qualification, periodic evaluation and/or requalification of new and/or existing Suppliers and Service Providers.
- Generate and manage the annual External and Internal Audit schedules employing a risk-based approach.
- Support the development of QA systems, Directives and SOPs.
- Support the implementation and continuous improvement of the eQMS.
- Support the development of SOPs, protocols, and reports for operations and validation activities related to the eQMS.
- Train personnel and provide technical support to users of the eQMS.
- Provide oversight of Quality Systems such as deviations, CAPAs, and change controls.
- Maintain records and generate reports for Quality management review.
- Participate in internal audits and support external audits.
- Support the Quality team during regulatory inspections.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
- BA/BS with 8+ years relevant experience in Quality operations or development in the biotechnology or pharmaceutical industry.
- Knowledge of FDA regulatory requirements for biologics or pharmaceuticals.
- Must have excellent communication and interpersonal skills and proven ability to establish collaborative relationships; team-oriented and able to work independently.
- Strong to excellent organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
- Must have the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Computer skills: proficient with Word, Excel, Visio, PowerPoint, and Adobe Acrobat.
- The ideal candidate is self-motivated and directed; works effectively independently as well as in a team environment.
- The incumbent in this position must be able to remain in a stationary position more than 50% of the time operating a computer, must have the ability to occasionally move about in the office to retrieve files and filing, and will regularly operate other office equipment such as calculator, copy machines, printers, etc.