The position is for a minimum of 4 months with the possibility of extension if work loads continue to rise.
Position will have a significant portion of at home work, with an expectation of approximately 50% on site given the current pandemic. Orientation will also be onsite the 1st week.
This position is responsible for processing AbbVie/Allergan Branchburg (Legacy LifeCell) documentation housed in the One Vault electronic document management system (EDMS). This responsibility includes managing document updates, processing change controls and participating in new system testing, as required. Seeking a newer college grad who is self-motivated, open to learning, with good communication skills and ability to complete work in a timely way.
Key Duties and Responsibilities:
Management and processing of documents in EDMS. 50%
Processing Change Controls, document revisions, documentation updates and reviews. 30%
Participating in new system testing and verification 10%
Other duties as assigned. 10%
Job Qualification (Minimum Requirements):
Education and Experience:
• BA or BS Degree, or equivalent experience
• 0-2 years of experience within a Documentation Services Group in Medical Device, Pharmaceutical, Human Tissue, or Biotech Industry.
• 0-2 years of experience working with electronic document management systems (preferably Veeva Vault Quality Docs, TrackWise, etc.), 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 and OneDrive is a plus.
• This is an entry level role, not appropriate for those with extensive experience in the industry.
Looking for Basic Skills, Experience and Exposure in the following areas:
• Assessing Change Control records and documentation.
• Experience reviewing, routing, and processing documents through electronic workflows in an electronic document management system.
• Understanding of regulatory requirements pertaining to documentation management systems and change controls.
• Knowledge of document formatting and editing.
• Takes Initiative
• Builds partnerships and relationships
• Ability to learn how to extract data from multiple sources for reporting and metrics purposes.
• Thinks creatively, works quickly, with 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.
|Will this position require driving? || || |
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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