QA Operations Specialist II
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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. health system. Led by seasoned healthcare and pharmaceutical professionals, 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, especially the uninsured or underinsured.
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, check out the article in BioSpace here.
Job Description
The QA Operations Specialist II will join Civica's Petersburg team, 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) and Good Distribution Practices (GDP).
Essential Duties And Responsibilities
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. health system. Led by seasoned healthcare and pharmaceutical professionals, 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, especially the uninsured or underinsured.
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, check out the article in BioSpace here.
Job Description
The QA Operations Specialist II will join Civica's Petersburg team, 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) and Good Distribution Practices (GDP).
Essential Duties And Responsibilities
- Support compliance in sterile fill-finish manufacturing of insulin and biologics.
- Collaborate with operations to develop compliant manufacturing batch records.
- Work cross-functionally on defect criticality and inspection methods.
- Act as a resource for colleagues and lead Quality Risk Management processes.
- Promote a safety and quality-first mindset.
- Ensure compliance with Civica and FDA/DEA regulations.
- Support material receipt, quality control, and release processes.
- Maintain knowledge of evolving FDA and Civica requirements.
- Lead or support documents, change controls, and CAPAs.
- Identify and resolve problems collaboratively.
- Lead department objectives with minimal supervision.
- Occasional travel may be required.
- 6 years of experience in pharmaceutical or medical device manufacturing.
- Strong project management and organizational skills.
- Technical problem-solving abilities.
- Experience with regulatory agency inspections.
- Excellent communication skills and proficiency in software applications.
- Self-motivated and adaptable in a fast-paced environment.
- Ability to work autonomously within guidelines.
- Commitment to high-quality results and continuous learning.
- Experience in Manufacturing Batch Record Design.
- Technical expertise in sterile pharmaceutical isolator technology.
- Knowledge of DEA requirements for controlled substances.
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