Quality Assurance Engineer II – Process and Validation

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 and one-third of U.S. hospital beds. The organization supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and 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 welfare.

Job Description

The Quality Assurance Engineer II will support quality systems at Civica’s Petersburg, Virginia facility, dedicated to essential generic sterile injectable medications. Responsibilities include ensuring compliance with cGMP and FDA requirements, overseeing validation processes, and generating necessary quality documentation.

Essential Duties:

• Provide Quality oversight for validation activities.
• Lead Quality Risk Management initiatives.
• Maintain knowledge of regulatory requirements.
• Support product process transfers and introductions.
• Assist with aseptic process simulations.
• Manage quality processes across the product lifecycle.
• Review laboratory method validations.
• Promote a quality and safety mindset.
• Travel may be required (up to 5%).

Basic Qualifications:

• Bachelor’s degree in a scientific discipline with 6+ years of Quality/cGMP experience.
• Experience in validation, LIMS, and Quality Risk Management.
• Knowledge of 21CFR Part 11 and data integrity.
• Strong project management and communication skills.
• Self-motivated and adaptable in a fast-paced environment.

Preferred Qualifications:

Technical expertise in sterile pharmaceutical isolator technology and medical devices.