Job Description

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at

The Associate QC Analyst Incoming will join the Civica, Inc. 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 ensure 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.

The position's responsibilities include, but are not limited to, overseeing the incoming sampling process, supporting quality control (QC) operations, performing QC testing, and 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 order 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. 

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with a minimum of 2+ years of Quality/CGMP experience in the pharmaceutical industry.
• Excellent written/oral communication skills and strong discipline in Microsoft Programs are 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. 

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