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Miles
Km80.5

Document Control Specialist (Temporary)

Pharmacyclics, Inc.

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Location: Sunnyvale, CA Posted Date: 4/9/2013 Position Type: Temporary Job Code: 394 Required Education: High school or equivalent

Description

Provide support to QA Document Control during the implementation of a new Electronic Document Management / Training Management system.

Key Accountabilities/Core Job Responsibilities:
Support the following Document Control projects:
Provide support for processing controlled documents through the change control process
Edit documents that are being routed for changes and revision ensure that changes are accurately tracked
Format and revise controlled documents from the current format into a new template, including Forms, Labels, Policies, Protocols, SOPs, Specs, Test Methods
Convert controlled forms to HTML and/or pdf formats for use in the controlled document system.
Work with reviewers of documents to ensure that review of documents are performed in a timely manner
Track in-process DCRs – obtain signatures
Filing Documents
Scanning
Provide support for training
Enter training information into training log
File training records in training folders
Audit training files
Archive inactive employee training files
Maintaining signature file
Filling requests
Archiving
Document Checkout
Logbooks
Lab notebook

Requirements

Qualifications / Experience:
4 years experience with documentation practices in an FDA-regulated environment
2 year experience creating, using and administering electronic document management tools
Must have extensive experience using Adobe Acrobat Professional, MS Access, Excel, Word,   and experience with SharePoint, Visio, Web-based document indexing and viewing applications.
Education Requirements (degree, certifications, etc.): Include must have and preferred
High school diploma with 4 years related experience and/or training or equivalent combination of education and experience.
Specific Skills/Abilities

General knowledge of electronic documentation systems, and electronic file formats
Ability to demonstrate initiative. Ability to organize work in an efficient manner and work well under time constraints
Must have experience using Adobe Acrobat Professional, MS Access, Excel, PowerPoint, SharePoint
Ability to multi-task and handle changing priorities as needed in a fast paced environment
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