Quality Assurance Engineer II
1 week ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced healthcare and pharmaceutical industry leaders is committed to ensuring that quality generic medications are accessible and affordable to everyone.
We have established a strong presence in the market, with over 55 health systems joining our organization. These health systems represent over 1,500 hospitals and one-third of all U.S. hospital beds. We have also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile with essential medicines.
Job DescriptionThe Quality Assurance Engineer II will play a critical role in our Quality organization at the Petersburg, Virginia site. This individual will be responsible for supporting quality systems and oversight to ensure that our product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems meet cGMP and Civica compliance requirements.
Responsibilities include:
- Providing quality oversight for validation and qualification activities
- Leading or participating in Quality Risk Management and analysis
- Maintaining current knowledge of local and international regulatory and legislative requirements
- Supporting and ensuring compliance of product process transfers
- Leading activities related to product introduction to the site
- Supporting aseptic process simulations
- Supporting quality processes and systems across the product lifecycle
- Providing quality review and support for laboratory method validation/verification and laboratory information management system (LIMS)
Basic Qualifications and Capabilities:
- Bachelor's degree in a scientific discipline with a minimum of 6 years Quality/cGMP experience in the pharmaceutical industry
- Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management
- Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity
- Strong project management, organization, and execution skills
- Participation and leading activities to support regulatory agency inspections
Preferred Qualifications:
Technical expertise in sterile pharmaceutical isolator technology, combination product, and medical devices
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