Quality Assurance Specialist

Summary

Join Dynavax, a biopharmaceutical company focused on developing and commercializing vaccines, as a Quality Assurance Specialist (Contractor). This remote position, based in the United States, will support various quality systems, including document control, training, quality records management, supplier management, audits, and quality event management. You will play a key role in implementing and maintaining the electronic Quality Management System (eQMS) company-wide. This position offers a highly flexible work environment with remote work and in-person meetings as needed.

Requirements

• 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

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

Benefits

We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary