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location: Northbrook, Illinois
job type: Contract
salary: $50.00 - 54.05 per hour
work hours: 9 to 5
- The position will provide support to Clinical & Research Quality Assurance (CRQA) Quality Systems for regulatory/quality intelligence and inspection readiness activities.
- Support regulatory intelligence:
- Performs searches (e.g., Cortellis, FDAzilla) on assigned topics and provides consolidated search result summary
- Review assigned regulations to identify relevant content to share with CRQA
- Updates relevant SharePoint sites with intelligence
- Communicates appropriate intelligence information to CRQA colleagues
- Creates flowcharts and graphs using MS Visio and MS Excel
- Support inspection readiness
- Develop PowerPoint presentations related to inspection readiness
- Provides project management support for inspection activities (Reviewing files, uploading documents to SharePoint, managing and tracking project deliverables, working with Subject Matter Experts to follow-up on action item status and deliverables, etc.)
- Communicates routine status updates for inspection preparation activities
- Additional tasks to support the CRQA Quality Operations team may be assigned as appropriate.
- Highly Proficient in MS Office applications (MS Word, MS Excel, MS PowerPoint, etc.)
- Highly Proficient in SharePoint
- Strong Typing and Organizational Skills
- Ability to multitask and manage daily tasks and projects
- Knowledge of the Good Clinical Practice regulations
- Strong communication skills
- Coordinate team meetings
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.