QC Specialist II Insulin

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 QC Specialist II Insulin will join Civica’s Petersburg, Virginia team, 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 crucial 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:

• Support the Insulin project and related activities.
• Conduct analytical testing and document results accurately.
• Participate in method transfers and verifications/validations.
• Report OOS, OOT, or atypical results promptly.
• Lead or assist in laboratory investigations.
• Perform HPLC analysis with minimal supervision; experience with Empower software is a plus.
• Maintain LIMS data.
• Promote a safety culture and maintain a clean work environment.
• Identify continuous improvement opportunities.
• Participate in 6S and OPEX initiatives.
• Work independently or collaboratively.
• Manage chemical inventory and order supplies as needed.
• Perform other duties as assigned.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with 8+ years in the pharmaceutical industry.
• Proficiency in LIMS, analytical data acquisition software, and Microsoft Office.
• Ability to multitask in a fast-paced environment.
• Self-motivated with a willingness to learn.
• Knowledge of FDA, ICH guidelines, and USP requirements.
• Experience with wet chemistry testing and HPLC analyses.
• Ability to prepare and review technical documents.
• Experience with analytical method transfers, verifications, and validations.