Administrative Assistant II
3 days ago
3 openings
6-month initial contract
Onsite
This role will be part of a team working on a 6-month, large scale project to assess and update impacted quality documents, so will need to be comfortable with working (1) as an individual, (2) as interactive team member and (3) with close supervision by direct manager and project manager.
Responsibilities may include the following and other duties may be assigned as needed for the project:
- Navigate Agile ERP System and download files.
- Conduct gap and compliance assessments of quality management system (QMS) documents against specified criteria for a regulation update.
- Be able to identify and articulate issues in Good Documentation Practices.
- Edit/redline needed changes in QMS documents.
- Create change orders in Agile and load files.
- Log progress and track assessment information in project files.
TECHNICAL SKILLS
Must Have
- Excellent attention to detail
- administrative and analytical support
- Proficiency with Microsoft suite - specifically Word, Teams and Sharepoint.
Nice To Have
- Acquired Microsoft certification
- Experience with CFR 820 and ISO 13485
- Experience with document gap and compliance assessments
- ii. Experience in document control/quality management systems
- Intermediate proficiency with Oracle Agile system
Autonomy: Established and productive individual contributor. Works on clerical and administrative assignments that may require application of prior experience. Works under moderate supervision, making minor adjustments to methods and processes.
Organizational Impact: Works to deliver on day-to-day objectives with direct impact on achievement of results. Work consists of tasks that are typically routine, with some deviation from standard practice.
Innovation and Complexity: Checks and makes minor adjustments to work methods to solve problems that are routine and typically exist in current work processes and systems. May be required to highlight areas of concerns/problems and puts forth solutions in own job area.
Requires minimum of 2 years of relevant experience.
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