QA Documents Specialist

South San Francisco, CA 94080

Posted: 01/11/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 14602

Recruitment for QA Documents Specialist
 
South San Francisco, CA

We are currently recruiting for QA Documents Specialist, reporting to the QA Manager. This position will be based in South San Francisco.

 

Responsibilities:

The ideal candidate is an experienced Documents Specialist with a track record of success in GLP and GMP environments. The job incumbent will be responsible for updating and filing documents, logs, and databases in support of compliance activities. Chain of identity control is central to the GMP process for autologous cell therapy, which is critical to this role. Will coordinate the review and revision of procedures, specifications and forms.  e ideal candidate is meticulous and detail-oriented in preparing process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.   Maintains electronic files to support documentation systems. Responsible for filing, retrieval and maintenance of master and reference documents. Receives, reviews, controls, and tracks documents per relevant process and procedures. Updates & Controls documents, logs, databases and assigns part numbers and routing additions, deletions, and changes. Controls engineering notebook distribution and retrieval. Identifies and implements improvements to the document control system. Trains personnel on document format, content, use, control, and the document control system. Thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint. Excellent verbal and written communication skills. Ability to build strong working relationships with multiple departments.

Minimal Qualifications:
  • Candidate must hold bachelor’ s degree or higher in relevant biological sciences.
  • Highly goal-driven approach and the ability to focus on time-sensitive objectives. 
  • 4+ years in industry with GMP/GLP quality assurance/control experience.

Jesse Ashworth

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