Associate 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 chronic 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. The organization prioritizes patient interests and has expanded its mission to include affordable medications at retail pharmacies through its sister organization, CivicaScript.

Recently, Civica announced plans to produce affordable biosimilar insulin, ensuring consistent availability for those in need. Long- and short-acting insulins will be priced at no more than $30 per vial and $55 for a pack of five pens.

For more information, visit www.civicarx.org.

Job Description:

The Associate Quality Control Laboratory Analyst will join Civica’s Petersburg, Virginia site, focusing on quality and compliance in the manufacture of essential sterile injectable medications. Responsibilities include performing analytical testing, maintaining equipment, and executing method verifications and validations.

This role is vital for ensuring that materials meet required standards for identity, strength, quality, and purity, supporting Civica’s mission to provide affordable, quality medicines.

Essential Duties and Responsibilities:

• Conduct analytical testing and document results accurately.
• Participate in method transfers and verifications/validations.
• Address OOS, OOT, or atypical results promptly.
• Engage in laboratory investigations.
• Promote a safety culture by following established procedures.
• Maintain a clean work environment per 6S principles.
• Contribute to continuous improvement initiatives.
• Work independently or collaboratively as needed.
• Manage chemical inventory and order supplies.
• Prepare technical documents like protocols and SOPs.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with 2+ years in a regulated lab environment.
• Proficiency in Microsoft Office applications.
• Ability to multitask in a fast-paced setting.
• Self-motivated with a willingness to learn.
• Familiarity with FDA, ICH guidelines, and USP requirements preferred.