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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
B.S. in any Science
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.
Last updated : 2024-09-10
Full Time
Business Services
$83k-102k (estimate)
09/12/2024
12/08/2024
techdigitalcorp.com
BURNSVILLE, MN
100 - 200
2008
BALAJI THIAGARAJAN
$10M - $50M
Business Services
The job skills required for Quality assurance specialist include Quality Assurance, Quality Management, Written Communication, Quality Management System, Presentation, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality assurance specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality assurance specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality assurance specialist positions, which can be used as a reference in future career path planning. As a Quality assurance specialist, it can be promoted into senior positions as a Quality Assurance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality assurance specialist. You can explore the career advancement for a Quality assurance specialist below and select your interested title to get hiring information.