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.
The Quality 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 overseeing the incoming sampling process. Responsibilities also include but are not limited to supporting quality control (QC) operations, performing QC testing, conducting, and documenting incoming inspection and sampling activities of components and raw materials.
Essential Duties and Responsibilities:
Work across functions to support the development and maintenance of incoming sample management.
Conduct and document material, component, and packaging sampling according to the established sampling plans.
Support the development of sampling plans across the product lifecycle.
Conduct sampling according to established procedures
Support and participate in testing and Acceptable Quality Level (AQL) checks and document the results using proper documentation practices.
Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
Support the shipment of samples to the appropriate external testing facilities as needed.
Complete laboratory inventory and ordering supplies as required.
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.
Minimum Qualifications (Knowledge, Skills, and Abilities):
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 Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.