Quality Assurance Professional
Company: Versiti, Inc.
Location: Aurora
Posted on: April 28, 2024
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Job Description:
Quality Assurance Professional
Job Locations
US-WI-Milwaukee - US-IL-Aurora - US-IN-Indianapolis - US-MI-Grand
Rapids
ID
2024-9884
Category
Quality
Position Type
Full Time
Overview
Versiti is a fusion of donors, scientific curiosity, and precision
medicine that recognize the gifts of blood and life are
precious.
We are home to the world-renowned Blood Research Institute, we
enable life saving gifts from our donors, and provide the science
behind the medicine through our diagnostic laboratories.
Versiti brings together outstanding minds with unparalleled
experience in transfusion medicine, transplantation, stem cells and
cellular therapies, oncology and genomics, diagnostic lab services,
and medical and scientific expertise. This combination of skill and
knowledge results in improved patient outcomes, higher quality
services and reduced cost of care for hospitals, blood centers,
hospital systems, research and educational institutions, and other
health care providers.
At Versiti, we are passionate about improving the lives of patients
and helping our healthcare partners thrive.
Position Summary
This role provides support to the Quality department in the area(s)
of quality, compliance and/or regulatory affairs. This role
supports the overall quality program and serves as a liaison
between the Quality team and other service lines of Versiti.
He/she/they partners with service lines to provide quality input on
projects and everyday tasks.
Responsibilities
* Supports Supervisor/Manager in executing the Quality Plan and
ensuring compliance with applicable regulations and standards.
* Identify and develop quality system improvements.
* May integrate continuous improvement practices adopted by Versiti
into quality systems, education, and improvement activities.
* May support internal/external assessments as assigned and
facilitates optimal communication between the department and the
inspector/assessors.
* Prepares charts, tables, etc. to analyze quality metrics. May
communicate results and actions of quality metrics.
* May review, approve and/or execute validation plans, corrective
action plans associated with events, and other required documents
for compliance as required.
* Supports operations with review of proposed changes in methods,
manufacturing, or instrumentation.
* May support with the development, compilation, and submission of
regulatory submissions as required.
* Review, analyze, approve, and monitor events logged in event
management system, including adequacy of investigation, quality of
documentation, and appropriateness of corrective and preventative
actions.
* May support Manager with the review of events to assess impact to
products/test results.
* Acts a resource for regulatory and quality matters.
* Identify emerging events in the applicable service line(s) and
assess product, donor, patient, and/or customer impact and
risk.
* Conduct problem surveillance (event reports, audit deficiencies,
customer complaints, supplier recalls, etc.) and work with
customers to effectively resolve problems.
* Perform review of nonconforming products. Participate in
decisions to determine product suitability for use, distribution,
or recall.
* Support organizational projects from a quality perspective and
complete assigned tasks in a timely manner.
* Ensure applicable service lines comply with the requirements of
the quality management system, as applicable.
* Serve as back up support to other Quality Assurance
Specialists.
* Actively participate in training, continuous improvement
activities and Lean initiatives.
* Perform other duties as assigned by direct supervisor or Quality
leadership.
Qualifications
Education
required
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Keywords: Versiti, Inc., Naperville , Quality Assurance Professional, Other , Aurora, Illinois
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