Quality - Quality Assurance Specialist

Quality Management System Administrator

Major duties 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 duties 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.