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Senior Quality Assurance Specialist
Apply
$103k-124k (estimate)
Full Time 1 Week Ago
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Axelon Services Corporation is Hiring a Senior Quality Assurance Specialist Near Bothell, WA

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.

Job Summary

JOB TYPE

Full Time

SALARY

$103k-124k (estimate)

POST DATE

06/18/2024

EXPIRATION DATE

07/06/2024

WEBSITE

axelon.com

HEADQUARTERS

New York, NY

SIZE

500 - 1,000

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