Quality Assurance Engineer II
4 days ago
About Civica Rx:
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 team of experienced health care and pharmaceutical industry leaders is dedicated to ensuring the quality and safety of our essential generic sterile injectable medications.
We are committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
Job Description:
The Quality Assurance Engineer II will join our team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance.
The Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities:
- Support quality systems and oversight to ensure the product process validation, cleaning validation, Quality Risk Management and quality laboratory systems meet cGMP and Civica compliance requirements.
- Lead or participate in Quality Risk Management and analysis.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends.
- Support and ensure compliance of product process transfers, including validation, from and/or to other manufacturing sites.
- Lead activities related to product introduction to the site.
- Support aseptic process simulations.
- Support quality processes and systems across the product lifecycle.
- Provide quality review and support for laboratory method validation/verification and laboratory information management system (LIMS).
- Provide support to equipment, facilities and utilities qualification as needed.
Requirements:
- Bachelor's degree in a scientific discipline with 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 is required.
- Strong project management, organization, and execution skills to manage multiple projects and priorities.
- Participation and leading activities to support regulatory agency inspections required.
Preferred Qualifications:
- Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.
Travel: Up to 5% may be required.
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