QA Operations Specialist

Job Description

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. CivicaScript, a new initiative, will manufacture affordable insulin for diabetes patients starting in 2024, addressing the financial burden on uninsured and underinsured individuals.

Job Description

The QA Operations Specialist will join Civica’s Petersburg, Virginia site, focusing on quality and compliance in the manufacture of essential generic sterile injectable medications. This role ensures compliance with regulatory standards, including Current Good Manufacturing Practices (cGMP).

Essential Duties and Responsibilities:

• Support compliance in sterile fill-finish manufacturing.
• Collaborate on batch record development to meet regulatory standards.
• Work cross-functionally on defect criticality and inspection methods.
• Act as a resource for colleagues and lead Quality Risk Management processes.
• Ensure compliance with FDA and DEA regulations.
• Maintain knowledge of evolving FDA and Civica requirements.
• Proactively identify and resolve issues collaboratively.

Basic Qualifications:

• Bachelor’s degree with 4+ years in a QA role in a cGMP environment.
• Strong problem-solving and project management skills.
• Excellent communication skills and proficiency in software applications.
• Self-motivated and adaptable in a fast-paced environment.

Preferred Qualifications:

• Experience in Manufacturing Batch Record Design.
• Technical expertise in sterile pharmaceutical isolator technology.
• Familiarity with Drug Enforcement Agency regulations.