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Scientist Quality Assurance

Location:
Milwaukee, WI
Posted:
May 07, 2021

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Resume:

SARAH WALTERS

**** **** **** ****, ********, WI *3033 · 262-***-****

adl8f4@r.postjobfree.com

To obtain a position that will enable me to use my experience in a regulated medical environment, superb attention to detail, background in writing controlled documents, and data collection and analysis experience to move healthcare forward.

EXPERIENCE

MARCH 2020 – PRESENT

QUALITY SPECIALIST I

IMMUCOR GTI DIAGNOSTICS

Investigate, analyze, and correct non-conformance events using Q-Pulse Quality Management System

Participate in internal and external audits by FDA and TUV

Perform final quality inspection of Immucor products to ensure medical device conformance prior to release to finished goods

Perform batch record review to ensure thoroughness and accuracy of quality records

Revise quality documentation to better define, improve, or clarify practices, process and/or product quality

Verify incoming materials meet required acceptance criteria and/or testing

MAY 2014 – MARCH 2020

LABORATORY SCIENTIST

Versiti – Bloodcenter of wisconsin at Children’s Wisconsin

Performed routine testing following CAP, CLIA, and FDA guidelines

Created and revised standard operating procedures in accordance with regulations and standards

Reported data in Midas+ Care Management to help Children’s Wisconsin manage, measure, and monitor quality and safety to improve patient outcomes

Tracked and trended events with SmartSolve CAPA Management to enhance product quality and patient safety

Conducted blood and blood product administration audits to ensure compliance with AABB Standards

JUNE 2011 – MAY 2014

CLIENT SERVICES & LIS STUDENT WORKER

Versiti – BLoodcenter of wisconsin

EDUCATION

MAY 2014

CLINICAL LABORATORY SCIENCE, Marquette University

Completed my clinical experience at the Milwaukee Veterans Affairs Medical Center.



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