San Francisco Metro Area,
Job Number: JN -072019-4376
Our client, a global life sciences leader, has an immediate need for a QA Documentation specialist to join its San Francisco Peninsula CA operations.
- 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).
- 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.
Having been in business since 2006, Vivo is a full-service recruiting and consulting company, specializing on mid to senior level technology resources. Our brand promise is simple: we get people. We get that our clients don t want to waste time, and that our candidates and employees thrive when given honest feedback and an opportunity to grow.
Whether you re onsite at our Pleasanton headquarters or working for one of Vivo s clients the best brand names out there our promise to you is unwavering: we will treat you like you are our most important employee.
Do you think you get people get what they really need, and get how to deliver? We re not perfect but we re accountable. We re not in 32 countries, but we are in the heart of it all. So, if you are looking for a flexible, fun and high-energy work environment, along with the opportunity to work with some of the world s technology leaders, we can t wait to talk to you.
Vivo We Get People!