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Quality Document Control

Location:
Louisville, Kentucky, United States
Posted:
September 10, 2018

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Resume:

Alicia Sonne

**** ***** ***** ******

Bardstown Ky. 40004

505-***-****

ac6z0d@r.postjobfree.com

Experienced Quality Control Leader in areas including medical devices, plastic product manufacturing, and technology

Skills

Document Control

Experience in both Internal and External ISO Audits

Process Improvement

Manage Value Added Services and specialty projects

Leadership

Visual and measured inspections using calipers, hardness tester, ruler, height gauge, go no-go gauges, pin gauges, optical comparator

Experience

03/2018-CURRENT

Quality Leader / Arvato Digital Services Louisville, Ky.

Maintain Quality Management System

Manage all document control including revisions, routing for approval and maintaining a schedule for regular review

Manage training program to keep all employees current in department specific training

Implement, investigate and manage all corrective actions (CARs, CAPAs, SCAPAs) from initiation through closure

Track building metrics for shipping, quality inspections, and non-conformances

Lead regularly scheduled management review meetings

Lead quality team in day-to-day operations

Lead both the internal audit program and ISO audits

07/2015-03/2018

Lead of Quality and Regulatory Affairs / Owens and Minor Louisville, Ky.

Lead of Quality Team and Value Added Services Area

Inspect/release incoming material including sterile product holds

Manage Value Added Service area for quality inspections, specialty orders for color coding, etching, kitting, packaging and labeling

Document control-create, edit, revise applicable documents and route through appropriate channels for review and approval

Processed requests for change control as instructed by client

Assist with both internal and external ISO audits

Assist in on-boarding new clients

Managed training program for cGDP

01/2014-06/2015

Field Supervisor / Protech Quality Solutions

Lexington, Ky.

Initiate new quality control projects including inspection, sorting an rework

Create job specific work instructions based on client request and route for approval

Organize and oversee team of inspectors performing each new project

Education

MAY 2002

Bachelor’s of Science in Nursing / Spalding University Louisville, Ky.



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