Quality - Quality Assurance Specialist - TechDigital

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.