QA Compliance Specialist II

About Civica

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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third 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 recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica’s innovative model is directly impacting patient care,  to read a summary from the New England Journal of Medicine. ((Use the "Apply for this Job" box below)..
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To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes,  to read an article in Bio Space. ()

The Quality Assurance (QA) Compliance Specialist II 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.

Lead aspects of quality and compliance to ensure compliance with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices), internal standards, and expectations for the development and reliable supply of quality medicines. Responsibilities include leading activities related to supplier qualification, change control, investigations and CAPA, complaints, Quality Risk Management, inspection readiness and metrics.

• Working across functions, participate in the implementation and maintenance of the site’s quality system framework including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients.
• Implement, track, trend, and analyze quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
• Lead the assessment, qualification, and approval of suppliers.
• Participate in or lead internal self-assessment audits.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Working across functions to ensure compliant document control and training programs.
• Lead or participate in Quality Risk Management and Data Governance Processes as needed.
• Participate in activities to support regulatory agency inspections.
• Support site objectives with a minimal amount of supervision.…