Quality Control Laboratory Analyst

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 availability for those in need. Insulin will be priced at no more than $30 per vial and $55 for a pack of five pens.

Learn more at www.civicarx.org.

Job Description:

The Quality Control Laboratory Analyst will join Civica’s Petersburg, Virginia site, focusing on analytical testing of sterile injectable products. Responsibilities include maintaining analytical equipment, executing method verifications, and ensuring compliance with regulatory standards.

Essential Duties:

• Conduct analytical testing and document results accurately.
• Participate in method transfers and validations.
• Report atypical results promptly.
• Engage in laboratory investigations.
• Perform HPLC analysis with minimal supervision.
• Maintain LIMS data and promote safety culture.
• Support continuous improvement initiatives.
• Manage chemical inventory and supplies.
• Complete additional tasks as assigned.

Qualifications:

• Bachelor’s degree in a scientific field with 5+ years in a regulated lab.
• Proficient in LIMS, analytical software, and Microsoft Office.
• Ability to adapt in a fast-paced environment.
• Knowledge of FDA and ICH guidelines preferred.
• Experience in wet chemistry testing and HPLC analysis.
• Familiarity with method transfers and validations.

Civica is an Equal Opportunity Employer and a drug-free workplace.