QA Associate - QA Specialist - QA Sr Specialist 10/8/2017

Dynavax Technologies Berkeley, CA

Location
Berkeley, CA
AJE Ref #
579710257
Job Classification
Full Time
Job Type
Regular
Company Ref #
375094
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

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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.