Quality Assurance Engineer II
18 hours ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.
Our mission is to ensure that patients have access to affordable, high-quality medications. We achieve this by developing and manufacturing essential generic sterile injectable medications.
Job DescriptionThe Quality Assurance Engineer II will join our team at the Petersburg, Virginia site, where we are building a new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
This role will support quality systems and oversight to ensure that our products meet cGMP and regulatory 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 product process transfers, including validation, from and/or to other manufacturing sites
- Leading activities related to product introduction to the site
- Supporting aseptic process simulations
- Supporting quality processes and systems across the product lifecycle
The ideal candidate will have a Bachelor's degree in a scientific discipline and 6+ years of Quality/cGMP experience in the pharmaceutical industry. They will also have experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management.
We are looking for a self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment. The ability to work autonomously and within established guidelines, procedures, and practices is essential.
Requirements- Bachelor's degree in a scientific discipline
- 6+ years of Quality/cGMP experience in the pharmaceutical industry
- Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management
- Strong project management, organization, and execution skills
- Excellent interpersonal and written communication skills
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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