This position can be 100% remote, but must be located in the United States.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B®, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults. We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines.

At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary. Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Düsseldorf, Germany.

The Quality Assurance Specialist (Contractor) is responsible for supporting activities related to Quality Systems including Document Control, Training, Quality Records Management, Supplier Management, Audits, and Quality Event Management (Deviation, CAPA, Change). This position will support the upgrade implementations and maintenance of the electronic Quality Management System (eQMS), which will be used company-wide for document control, training, and management of Quality events such as deviations, complaints, and CAPAs.

Responsibilities

Administer the Document Control program. Support the development of QA systems, Directives, and SOPs.
Administers the Training Program. Trains personnel and provide technical support.
Support the implementation and continuous improvement of the eQMS by collaborating on the development of SOPs, protocols, and reports for operations and validation activities.
Administer the QA archive (controlled documents), including filing/retrieving of records and creation/distribution of copies of archive materials.
Supports the oversight of Quality Events such as deviations, CAPAs, and change controls, where these events impact Quality Systems they administer (documents, training, records, etc.).
Maintain records and generate reports for Quality management review.
Supports internal and external audits. Support the Quality team during regulatory inspections.
Support 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.
Support the generation and management of the annual External and Internal Audit schedules employing a risk-based approach.
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.

Qualifications

Minimum 3 years relevant experience in Quality Assurance in the biotechnology or pharmaceutical industry.
Experience with an electronic quality management system (e.g., document control/training system).
Knowledge of FDA regulatory requirements for biologics or pharmaceuticals.
Must have excellent communication and interpersonal skills and proven ability to establish collaborative relationships and work within a team-oriented environment.
Must have the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
Self-motivated and directed; works effectively independently but willing to seek guidance as appropriate.
Strong technical writing and editing skills.
Proficient with Word, Excel, Visio, PowerPoint, and Adobe Acrobat.
Ability to sit for prolong periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.
Occasional travel required, as needed.