Quality Assurance Specialist (Contractor)

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.