Documentation Specialist

Location: Los Gatos, CA, United States
Date Posted: 12-05-2016
Job Title :Documentation Specialist
Location: Los Gatos, CA.
Optional Ref#:5922163

Job Description:

This individual is part of the Quality team of GeneWEAVE Biosciences, a life science startup subsidiary of Client Molecular Diagnostics.
GeneWEAVE is developing a transformative diagnostic platform and cutting-edge diagnostic assays for infectious diseases.
We are seeking a seasoned documentation candidate familiar with US FDA regulations for medical devices (cGMP, GLP, GCP) and ISO 13485. The QA Documentation Specialist will be working in a fast-paced, interdisciplinary team that will demand exceptional support, thoroughness and attention to detail, excellent verbal and written communication
and editing skills, strong execution and organizational skills, and the ability to work independently and in teams.

This position is responsible for coordinating the document and change control process, document support for development and design history files, and document support for manufacturing.
Provides superb customer support while ensuring compliance to regulatory requirements and internal policies and procedures.
Coordinate Document Control process. Assign document numbers and part numbers in compliance with document numbering structure. Secure and control document master files and obsolete files to maintain traceability and prevent misuse. Ensure current revisions are available at points of use. Coordinate periodic document reviews.
Coordinate QA Document Change Orders (DCOs). Provide guidance to document initiators in document formatting according to the templates and Standard Operating, Procedures (SOPs).
Format documents according to templates. Ensure complete DCO packages, route for approval, make effective, update change control log. Print, scan, and file documents. Post in approved locations. Send training notification for new and revised documents.
Set up training records for new employees and manage training matrix. Collaborate with supervisors to ensure training records are updated. Coordinate training.
Ensure quality records and reports are reviewed, organized and filed. Maintain records and logs.
Support internal and external audits.

Experience Required:
Bachelor's degree in Life Science, Engineering, Computer Sciences or another related discipline or comparable experience.
Minimum of 4 years related experience in document control, quality records management.
Microsoft Word expertise with a solid understanding of the review and formatting

Tools required.
Visio, Excel, Trackwise and PowerPoint competencies.
Excellent organization and attention to detail.
Excellent verbal and written communication including spelling, grammar and editing

Strong interpersonal skills, ability to work independently and in teams.
Experience with US FDA regulations for medical devices, plus international

Experience with IVD products, following applicable guidelines, is preferred.

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
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