Quality Assurance Engineer – Facilities and Equipment

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 a team of healthcare and pharmaceutical experts, 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 the Strategic National Stockpile.

Recently, Civica announced CivicaScript, a unit focused on manufacturing affordable insulins for diabetes patients, set to launch in 2024. This initiative will help those struggling to afford life-saving medications.

Civica’s mission is to ensure accessible, affordable quality generic medications for all, guided by the principle of “Do What Is in the Best Interest of Patients.” The Petersburg, Virginia facility, currently under construction, will produce affordable insulin and essential sterile injectable medicines.

For more on Civica’s impact on patient care, read a summary from the New England Journal of Medicine here.

To learn about Civica’s plans for affordable insulin, read an article in BioSpace here.

Job Description

The Quality Assurance Engineer – Facilities and Equipment will join Civica’s Quality organization at the Petersburg site, focusing on quality and compliance in the manufacture of essential generic sterile injectable medications.

Key responsibilities include maintaining quality systems to ensure compliance with cGMP and FDA requirements, overseeing validation and qualification of facilities and equipment, and generating necessary quality documentation.

Essential Duties and Responsibilities:

• Ensure GMP compliance of facility, equipment, and processes.
• Provide quality oversight for validation and qualification activities.
• Stay updated on regulatory requirements to support quality-related matters.
• Support product and process transfers, ensuring compliance.
• Oversee quality processes across the product lifecycle.
• Review calibration and maintenance programs for GMP compliance.
• Participate in quality risk analysis and problem resolution.
• Promote a quality and safety mindset in all operations.
• Travel (up to 5%) may be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with 4+ years of Quality/cGMP experience.
• Experience in facility qualification, process validation, and calibration programs.
• Knowledge of 21CFR Part 11 and data integrity.
• Strong project management and organizational skills.
• Experience with regulatory agency inspections.
• Self-motivated and adaptable in a fast-paced environment.
• Ability to work autonomously and collaboratively.
• Quality subject matter expert for investigations.
• Commitment to high-quality results and continuous improvement.
• Excellent communication skills and proficiency in software applications.

Preferred Qualifications:

• Experience in product development and commercialization lifecycle.
• Technical expertise in sterile pharmaceutical isolator technology.

PandoLogic. Keywords: Quality Control / Quality Assurance Engineer, Location: Petersburg, VA – 23803, PL: 594917034