Quality Assurance Engineer
4 weeks 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 quality generic medications are accessible and affordable to everyone.
We are led by an experienced team of healthcare and pharmaceutical industry leaders, with a strong commitment to delivering high-quality results and working collaboratively to overcome challenges.
Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Civica Rx. As a Quality Assurance Engineer, you will play a critical role in supporting 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.
Key Responsibilities- Support quality systems and oversight to ensure compliance with cGMP and Civica requirements
- Work with validation and engineering teams to provide Quality oversight for validation and qualification activities
- Participate in Quality Risk Management and analysis
- Maintain current knowledge of local and international regulatory and legislative requirements and trends
- Support product process transfers, including validation, from and/or to other manufacturing sites
- Support 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
- Bachelor's degree in a scientific discipline with 4+ 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
- Participation and leading activities to support regulatory agency inspections required
- Project management, organization, and execution skills are required
- Ability to apply technical expertise to solve problems and issues
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment
- Ability to work autonomously and within established guidelines, procedures, and practices
Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices
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