Quality Assurance Engineer – CSV

Job Description

About Civica

Civica, a 501(c)(4) social welfare organization founded in 2018, aims to alleviate chronic generic drug shortages and high prices in the U.S. Led by seasoned healthcare and pharmaceutical leaders, Civica has over 55 health systems as members, representing 1,500+ hospitals. The organization supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile.

Recently, CivicaScript was launched to manufacture affordable insulins for diabetes patients, set to be available in 2024. Civica’s mission is to ensure quality generic medications are accessible and affordable, with a focus on patient interests.

Job Description

The Quality Assurance Engineer will join Civica’s Quality team at the Petersburg, Virginia site, dedicated to producing essential generic sterile injectable medications. Responsibilities include maintaining quality systems to ensure compliance with cGMP and FDA requirements, overseeing computerized systems, and generating necessary quality documentation.

Essential Duties and Responsibilities:

• Ensure GMP compliance for facility, equipment, and processes.
• Provide quality oversight for computerized system validation.
• Maintain knowledge of regulatory requirements and data integrity.
• Support quality processes across the product lifecycle.
• Participate in quality risk analysis and problem resolution.
• Promote a quality and safety mindset in all operations.

Basic Qualifications:

• Bachelor’s degree in a scientific discipline or computerized systems with 4+ years of experience.
• Experience in computer system validation oversight.
• Knowledge of 21CFR Part 11 and data integrity.
• Strong project management and communication skills.
• Self-motivated and able to work in a fast-paced environment.

Preferred Qualifications:

• Experience in facility and equipment qualification.
• Technical expertise in sterile pharmaceutical technology.

Physical Demands:

This role requires on-site presence for 80% of the work week, with one remote day allowed.