Quality Assurance Shop Floor Tech

Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to combat these shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to “Do What Is in the Best Interest of Patients.”

Recently, Civica launched CivicaScript to reduce pharmacy costs and announced plans to produce affordable biosimilar insulin, ensuring consistent access for those in need.

Job Description

The Quality Shop Floor Associate will support Civica’s Petersburg, Virginia facility, dedicated to manufacturing essential generic sterile injectable medications. Responsibilities include quality support, documentation review, and maintaining compliance with FDA requirements.

Essential Duties:

• Review materials and components.
• Inspect finished goods.
• Ensure adherence to SOPs and batch records.
• Document nonconformances and deviations.
• Support all manufacturing areas.
• Promote quality and safety mindsets.
• Maintain up-to-date SOPs and training.
• Follow good documentation practices.
• Stay informed on FDA and Civica requirements.
• Collaborate to resolve issues.

Basic Qualifications:

• High school diploma.
• Strong organizational skills.
• Excellent communication skills.
• Self-motivated and adaptable.
• Ability to work autonomously.
• Commitment to quality results.
• Desire to learn and share knowledge.

Preferred Qualifications:

• Experience in the pharmaceutical industry.
• Quality Assurance experience.

For more information, visit www.civicarx.org.