IT Document Specialist II
Foster City, CA

Job Description

IT Document Specialist II Req I D

GS-6391

Rate

Primary Skills

Description

Responsibilities:

* Processes IT and computer system-specific controlled documents such as policies, procedures, work instructions, forms, specifications, protocols, reports, and test documentation in the Electronic Document Management System (EDMS) following defined processes/procedures.
* Performs review of documents submitted through the change control process for format, completeness, review, and approvals.
* Manages and troubleshoots review/approval/obsoletion/retirement workflows within EDMS/QDMS.
* Scans, verifies, and archives IT paper records in accordance with record retention requirements. Verifies the consistent application of Good Documentation Practices.
* Works with IT staff to establish priorities and deadlines for processing IT documentation.
* Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
* Performs general word processing tasks and supports the production of IT documentation per document templates and style guides. Assists IT staff to design and implement fillable forms and templates.
* Ensures the correct and timely implementation of Document Change Controls (DCCs)/Change Requests (CRs). Analyzes DCCs/CRs for completeness. Communicates with IT staff to ensure changes are concise and complete.
* Routes documents for review and approval in EDMS/QDMS. Ensures that review comments, tracked changes, and impacted documents are addressed. Ensures the integrity of document references.
* Notifies training coordinators of new and revised IT procedures, ensuring training assignments are updated as required.
* Ensures that the periodic review of IT documentation is correctly scheduled, assigned, and initiated in the QDMS, and is completed in a timely manner.
* Identifies deviations from document control procedures. Notifies IT management and assists with issue resolution.
* Provides document control process metrics for management review.
* Provides support for internal and regulatory audits/inspections as required.
* Supports the administration of, and uses, the Learning Management System (LMS).

Knowledge, Experience and Skills:

* Demonstrates strong working knowledge of Document Control fundamentals, Quality Systems, and GxP requirements.
* Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS) or Quality Document Management Systems (QDMS), such as VeevaVault Quality Docs or similar (in a GxP environment is preferred), including relevant experience with managing and troubleshooting review/approval/obsoletion/retirement workflows and document classification/metadata.
* Demonstrates strong working knowledge of Learning Management Systems (LMS), such as UL Compliance Wire or similar (in a GxP environment is preferred). Using above management systems in a GxP environment is preferred. Relevant experience with administering LMS is a plus.
* Demonstrates strong verbal, technical writing, and interpersonal skills.
* Demonstrates effective organizational, planning, and time management skills.
* Demonstrates high attention to detail, while service-oriented, with the ability to process high volumes of Document Change Controls (DCCs)/Change Requests (CRs) in a timely, prioritized and compliant manner. Experience with managing multi-document change control is preferred.
* Demonstrates strong computer skills with software used in document processing, which includes MS Excel, Word, Adobe Acrobat.
* Relevant experience with managing paper records, including creating true electronic copies, archiving originals in offsite storage, and use of a records management system, such as FileTrail or similar (in a GxP environment is preferred).
* 3+ years of relevant experience in a regulated industry. Experience with IT operations and direct documentation management in a GxP pharmaceutical setting is preferred, including extensive experience with GDP.