Dynavax Technologies

Specialist – Senior Specialist, GLP/GMP Compliance

US-CA-Berkeley
4 weeks ago(11/20/2017 2:34 PM)
ID
17-068N
Category
Quality Control/Assurance

Overview

The QA Specialist / Senior Specialist will be responsible for supporting all quality assurance activities related to development and commercial programs and products including, but not limited to,  batch manufacturing and testing records, labelling, packaging and shipping records, QC test results, deviations, change requests SOP and batch record generation and revision, and the generation of documentation metrics.   

The senior specialist may be part of a dynamic QA team responsible for CMO compliance and final product release.

Responsibilities

  • Review batch manufacturing and testing records to ensure compliance with GLP, cGMP and 21 CFR in support of product release.
  • Prepare lot release package.
  • Track and trend batch record errors.
  • Initiate incident reports during batch record review and provide support during investigations.
  • Create and revise SOPs, and prepare documents for review and approval, as required.
  • Review deviations/CAPAs and change requests.
  • Actively participate in internal audits and support during regulatory inspections, as required.
  • Generate and maintain quality metrics, as required.
  • Assist and may lead on special projects with moderate complexity and other responsibilities, as assigned.

Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration and teamwork

Qualifications

  • For the QA Specialist, at least 6 years’ relevant experience. For the Senior QA Specialist, a BA/BS is highly desirable, with 8+ years’ relevant experience.
  • Proven ability to understand and review manufacturing and QC test records, and related documentation, with attention to detail.
  • Strong to excellent technical writing and editing skills.
  • Computer skills: Proficient with Word, Excel, Visio, PowerPoint and Adobe Acrobat.
  • Effective verbal and written communicator, with proven ability to communicate complex information and concepts with clarity.
  • Strong to excellent organizational skills, with the ability to effectively prioritize, manage multiple projects and tasks, with great attention to detail.
  • Proven 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

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