Quality Assurance Engineer – 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 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-sustaining medications.

Civica’s mission is to ensure accessible, affordable quality generic medications for all, guided by the principle of prioritizing patient interests. Their Petersburg, Virginia facility is nearing completion and will produce affordable insulin and sterile injectable medicines.

For more on Civica’s impact on patient care, read the New England Journal of Medicine summary here. To learn about their plans for affordable insulin, check out the article in BioSpace here.

Job Description

The role involves supporting quality systems to ensure compliance with cGMP and Civica standards, facilitating FDA approval for the facility and new medications. Responsibilities include generating and reviewing policies, procedures, and reports to maintain quality oversight.

Essential Duties and Responsibilities:

• Provide Quality oversight for validation and qualification activities.
• Participate in Quality Risk Management and analysis.
• Stay updated on regulatory requirements to offer expert advice.
• Support product process transfers and introductions.
• Assist with aseptic process simulations.
• Manage quality processes across the product lifecycle.
• Review laboratory method validation and LIMS.
• Support equipment and facilities qualification.
• Collaborate to resolve problems with compliant solutions.
• Promote a quality and safety mindset in operations.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with 4+ years of Quality/cGMP experience.
• Experience in process validation, LIMS, and Quality Risk Management.
• Knowledge of 21CFR Part 11 and data integrity.
• Experience with regulatory agency inspections.
• Strong project management and problem-solving skills.
• Excellent communication skills and proficiency in software applications.
• Self-motivated and adaptable in a fast-paced environment.
• Committed to high-quality results and continuous learning.

Preferred Qualifications:

Technical expertise in sterile pharmaceutical isolator technology and medical devices.