Quality Assurance Specialist (Contractor)

Summary: The Quality Assurance Specialist (Contractor) at Dynavax is responsible for supporting Quality Systems activities, including Document Control, Training, and Quality Event Management. This role involves the implementation and maintenance of an electronic Quality Management System (eQMS) and requires collaboration across various departments to ensure compliance with regulatory standards. The position is fully remote but candidates must be located in the United States. The company emphasizes a culture of quality, integrity, and teamwork in the biopharmaceutical industry.

Key Responsibilities:

• Administer the Document Control program and support the development of QA systems, Directives, and SOPs.
• Administer the Training Program, train personnel, and provide technical support.
• Support the implementation and continuous improvement of the eQMS by developing SOPs, protocols, and reports.
• Administer the QA archive, including filing/retrieving records and creating/distributing copies of archive materials.
• Support oversight of Quality Events such as deviations, CAPAs, and change controls.
• Maintain records and generate reports for Quality management review.
• Support internal and external audits and assist during regulatory inspections.
• Support the Dynavax Supplier Management Program, including qualification and evaluation of Suppliers and Service Providers.
• Manage the annual External and Internal Audit schedules using a risk-based approach.
• Foster a work environment focused on quality, learning, respect, and teamwork.
• Other duties as assigned.

Key Skills:

• Minimum 3 years relevant experience in Quality Assurance in the biotechnology or pharmaceutical industry.
• Experience with an electronic quality management system.
• Knowledge of FDA regulatory requirements for biologics or pharmaceuticals.
• Excellent communication and interpersonal skills.
• Ability to proactively resolve issues diplomatically and constructively.
• Strong organizational skills with attention to detail.
• Self-motivated and directed, able to work independently.
• Strong technical writing and editing skills.
• Proficient with Word, Excel, Visio, PowerPoint, and Adobe Acrobat.
• Ability to perform office-related tasks including prolonged sitting and repetitive movements.
• Occasional travel required.

Salary (Rate): undetermined

City: undetermined

Country: United States

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other