Quality Systems Associate
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.
Intro to Civica
The Quality Systems 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 include but are not limited to supplier and material qualification, audits, and inspections. The Quality Systems Associate will assist in developing processes and procedures in support of the Quality Management system consistent with Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs).
Essential Duties and Responsibilities:
- Working across functions to support the establishment and maintenance of the site’s quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients
- Support the development and/or improve quality processes and systems across the product lifecycle including supplier and material qualifications, internal self-inspections, and regulatory inspections
- Ensure quality agreements are established for GMP suppliers and service providers
- Monitor and conduct self-inspections/audits on the shop floor
- Review and approve GMP documentation
- Support CGMP compliance and inspection readiness within organization
- Ensure that procedures are being followed as outlined under FDA, DEA, ISO, USP and CGMP guidelines
- Track, trend, and analyze quality system data and information for the site
- Participate and/or lead various Quality Systems processes including change controls, investigations, and corrective and preventative action (CAPA) plans
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions
- Practice and promote a safety and quality mindset and quality excellence approach to all activities
Basic Qualifications and Capabilities:
- Bachelor’s degree in a scientific discipline with a minimum of 3 years Quality/CGMP experience in the pharmaceutical industry.
- Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Ability to work autonomously within established guidelines, procedures, and practices.
- Committed to delivering high quality results, overcoming challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills and share learning.
Experience in the manufacture of sterile injectable pharmaceutical products is preferred