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AboutCivica
Civicais a 501(c)(4) social welfare organization established in 2018 by healthsystems and philanthropies to reduce chronic generic drug shortages and relatedhigh prices in the United States. Civica is led by an experienced team ofhealthcare and pharmaceutical industry leaders.
Today,more than 55 health systems have joined Civica. They represent over 1,500hospitals and one-third of all U.S. hospital beds. Civica has also begun tosupply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defenseand the U.S. Strategic National Stockpile of essential medicines.
Civicarecently announced plans to expand its mission, via a unit called CivicaScript,to into the outpatient pharmacy space and to manufacture and distributeinsulins that, once approved, will be available to people with diabetes atsignificantly lower prices than insulins currently on the market. Theavailability of Civica’s affordable insulins, beginning in 2024, will benefitpeople with diabetes who have been forced to choose between life sustainingmedicines and living expenses, particularly those uninsured or underinsured whooften pay the most out of pocket for their medications.
Civica’smission is to ensure that quality generic medications are accessible andaffordable to everyone. Since established, the #1 Policy for the Civica teamhas been “Do What Is in the Best Interest of Patients.” Civica’smanufacturing facility in Petersburg, Virginia, is the future home ofaffordable insulin and essential sterile injectable medicines. The facility iscurrently in late-stage construction and hiring for the site is well-underway.
To findout more about how Civica’s innovative model is directly impacting patientcare, click here to read a summary from the NewEngland Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learnmore about Civica’s plans to bring affordable insulin to Americans living withdiabetes, click here to read an article in BioSpace.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Job Description
The QA Operations Specialist 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 this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.
Essential Duties and Responsibilities:
Basic Qualifications and Capabilities:
Preferred Qualifications:
Full Time
$104k-125k (estimate)
04/11/2024
06/09/2024
civicarx.org
Lehi, UT
<25
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