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Senior Quality Assurance Specialist
4 months ago
This is a W2 contract role. No C2C/corp to corp
Pay Range : $80 to $88 per hour on W2
Job Description:
Quality Systems support within Quality Operations. Ensure that *** Co. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and the principles of Client directives.
Major duites and responsibilities:
- Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and metrics.
- Investigation & CAPA Review Board Administrator. Compile slides and assemble presentations, schedule logistics, meeting facilitation, and author meeting minutes.
- QMS Deviation and CAPA phase tracking and due date monitoring. Ensure adherence to deviation and CAPA due dates and extension process.
- Deviation Trending Program administrator. Perform quarterly analysis and identification of adverse trends. Author quarterly deviation trend report. Work cross-functionally to determine remedial actions to reduce recurrence and implement effective CAPAs.
- Deviation Trend Review Board logistics, preparation, facilitation, and meeting minutes.
- Perform routine and ad hoc queries of Quality Management System to support business operations.
- Other duites as assigned by manager
Education:
- B.S. in any Science
Experience / Knowledge Desired:
- A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems. (Veeva experience preferred)
- Advanced Excel knowledge and proficiency. Pivot table and reporting proficiency.
- Advance Smartsheet Dashboard Creation
- Technical report authoring experience. e.g. Deviation Trend Report
- Must exercise accurate judgment and be able to evaluate information critically and decide upon the appropriate course of action.
- Must be able to correlate events and determine the action plan required to avoid recurrence.
- Excellent verbal and written communication skills are essential.
- Excellent interpersonal skills at every level.
- Capable of managing priorities and timelines.
