We are hiring a Clinical Documentation Specialist near San Jose, CA!
San Jose Metro Area, CA
- Perform daily activities related to the document and record management process, document support for development, and training system.
- Provides superb customer support while ensuring compliance to regulatory requirements and internal policies and procedures.
- Secures and controls legacy development files and obsolete files to maintain traceability and prevent misuse.
- Ensures obsolete revisions are removed from points of use.
- Provides guidance to document initiators in document formatting according to approved procedures, templates and standards, such as routing, tracking of document status, approval notification, version control.
- Formats documents according to templates.
- Ensures complete Change Requests, monitor approval.
- Collaborates with supervisors to assign training requirements for new employees. Enters group training records in training system. Runs proactive training gap reports.
- Supports Development in creation, maintenance and design transfer of BOMs, part specifications, and manufacturing drawings and instructions to Production.
- Ensures quality records and reports are reviewed, organized, scanned and filed. Retains and manages records according to company record retention requirements.
- Supports internal and external audits.
- Provides documents and data records in a timely fashion.
- Participates in audit preparation, meetings, and responds to questions related to job function. Manages requests in audit ready room.
- Maintains office supplies for Quality department.
- AA or Bachelor s Degree, or high school degree with equivalent experience.
- 3-5 years related experience in quality records management in a cGMP environment.
- Excellent organization and attention to detail.
- Excellent verbal and written communication including spelling, grammar and editing skills.
- Strong interpersonal skills, ability to work independently and in teams.
- Microsoft Word expertise with a solid understanding of the review and formatting tools required.
- Visio, Excel, and PowerPoint competencies.
- EDMS electronic document management system and/or LIMS experience.