Dynavax Technologies

QA Associate - QA Specialist - QA Sr Specialist

US-CA-Berkeley
1 week ago
ID
17-042N
Category
Quality Control/Assurance

Overview

The QA specialist position is responsible for supporting activities related to Quality Systems including Document Control, Quality Records Management, Training, Supplier Management, Auditing, and Quality Event Management (Deviation, CAPA, Change). The position will support the implementation 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.

We anticipate that an incumbent at the QA Associate will have less independence while the QA Senior Specialist will function more independently based on the experience.

Responsibilities

  • 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.
  • Administer the QA archive controlled document room, including filing/retrieving of records and creation/distribution of copies of archive materials.
  • 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.

Qualifications

  • For the QA Associate, technical writing skills with 4 years’ experience in document management, preferably supporting Quality Assurance for pharmaceutical quality systems. For the QA Specialist, at least 6 years relevant experience. For the Sr QA Specialist, a BA/BS is highly desirable with 8+ years relevant experience.
  • Strong to excellent technical writing and editing skills.
  • Computer skills: proficient with Word, Excel, Visio, PowerPoint, and Adobe Acrobat.
  • Must be an effective verbal and written communicator with proven abilities to communicate complex information and concepts with clarity.
  • 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.
  • 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.
  • While the position will be based in Berkeley, CA, the incumbent shall be available for occasional travel, domestic and international, once or twice per year.

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