Edison-New Brunswick Metro Area, NJ
We are looking for a new round of candidates. The main things the previous candidates were lacking were more around the data collection and data migration activities. The couple of candidates who did have these skills didn t not have them with a Quality system (e.g. doc management system, TrackWise, etc.), they were more along the business systems such as Oracle or SAP. We are looking for candidates with documentation management experience within EDMS systems.
They need to be well versed in data collection, metrics reporting, TrackWise workflow have experience with performing data analysis and data migration activities for enterprise scale Quality systems (1-2 systems preferred). Strong attention to detail and ability to identify and report inconsistencies and errors during test migrations. Ability to execute test scripts and resolve issues.
This position is responsible for processing all documentation housed in the electronic document management system (EDMS) and distributed copies used throughout the company. This responsibility includes the Change Control Process and the distribution and archiving of all controlled paper and electronic documentation. This individual is also responsible for updating metrics and processing change controls, as required.
Education and Experience
BA or BS Degree, or equivalent experience - Required
Minimum 1 year of experience within a Documentation Services Group in Medical Device, Pharmaceutical, Human Tissue, or Biotech Industry.
1 - 2 years of experience working with electronic document management systems, as well as Change Control or Change Management systems/workflows.
3 - 5 years of experience with Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook; knowledge of SharePoint is a plus.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
Demonstrated knowledge of document handling, formatting, and editing.
Timely reporting and ability to extract data from multiple sources for reporting and metrics purposes.
Able to think creatively, work quickly, and have strong attention to detail.
Excellent oral and technical writing skills, with the ability to interface effectively and professionally
Demonstrated ability to multi-task and work independently.
Experience with GMP and ISO 9001 Document and Data Control requirement.
Experience with manual records and conversion to automated systems.
Experience assessing Change Control records and documentation.