Quality Assurance Associate
Company: Civica Rx
Location: Petersburg
Posted on: May 16, 2022
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Job Description:
About Civica Over the past two decades, shortages of generic,
injectable medications critical to the lifesaving work of hospitals
in the United States have become commonplace. Approximately 200
medically necessary drugs are on the U.S. Food and Drug
Administration's shortage list. Manufacturing challenges and
predatory pricing are both the cause and result. Who suffers most?
Patients. Civica is a 501(c)(4) social welfare organization
established in 2018 by health systems and philanthropies to reduce
chronic generic drug shortages and related high prices in the
United States. Led by an experienced team of health care and
pharmaceutical industry leaders. Today, more than 50 health systems
have joined Civica. They represent over 1,200 hospitals and over 30
percent of all U.S. hospital beds. Civica has also begun to supply
the U.S. Department of Veteran's Affairs, the U.S. Department of
Defense, and the U.S. Strategic National Stockpile of essential
medicines. Civica is improving patient outcomes and reducing
healthcare costs by making strides to ensure patients and their
needs come first and that essential generic medications are
accessible and affordable. Since established, the #1 Policy for the
Civica team has been "Do What Is in the Best Interest of Patients."
Civica is launching a subsidiary to enter the Outpatient pharmacy
market partnering with Blue Cross Blue Shield with the goal of
reducing drug prices, especially high-cost generic drugs where
market forces are not working to control drug costs. To find out
more about how Civica's innovative model is directly impacting
patient care, click here to read a recent article from the New
England Journal of Medicine. Watch this video to learn more about
Civica! Job Description: The Quality Assurance Associate will join
the Civica, Inc. ("Civica") organization and its newly forming team
at the Petersburg, Virginia site by bringing their knowledge and
experience in service to patients and pursuit of excellence in
quality and compliance. The Petersburg site serves as Civica's new
fill finish facility dedicated to the manufacture and supply of
essential generic sterile injectable medications. The role is
essential to assure the Petersburg site's manufacturing and
operations activities comply with applicable regulatory standards
(e.g., Current Good Manufacturing Practices, Good Distribution
Practices) and expectations for the development and reliable supply
of quality medicines. Responsibilities of the position include
establishing and maintaining quality and compliance processes
associated with sterile manufacturing and operations from the onset
of building and qualifying the facility leading to successful U.S.
Food and Drug Administration (FDA) approval of the facility and the
ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, batch record
development and review, approval of policies, procedures, reports
and other records necessary to support the design, implementation,
and maintenance of manufacturing processes that meets or exceeds
FDA requirements. Essential Duties and Responsibilities:
Keywords: Civica Rx, Richmond , Quality Assurance Associate, Other , Petersburg, Virginia
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