Quality Assurance Engineer
3 days 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 focus on quality and compliance. Our manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines.
Job DescriptionThe Quality Assurance Engineer will join our team at the Petersburg, Virginia site, 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 of the position include maintaining quality systems and oversight to ensure the validation/qualification and operation of computerized systems meet cGMP and regulatory compliance requirements. This includes generating, reviewing, and approving policies, procedures, reports, and other records necessary to provide quality oversight of our Engineering functions.
Essential Duties and Responsibilities:
- Ensure the site's quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.
- Work with validation and engineering teams to provide Quality oversight for computerized system validation activities.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends.
- Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
- Support quality processes and systems across the product lifecycle.
- Participate or lead in quality risk analysis.
- Proactively identify and work collaboratively to resolve problems.
- Promote a quality mindset and quality excellence approach to all activities.
Basic Qualifications and Capabilities:
- A bachelor's degree in a scientific discipline or computerized systems with a minimum of 4+ years relevant experience.
- Experience providing computer system validation oversight.
- Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.
- Experience in developing and managing scientific studies, identifying critical aspects of the topic being studied, and defining appropriate acceptance criteria.
- Strong project management, organization, and execution skills to manage multiple projects and priorities.
- Participation and leading activities to support regulatory agency inspections.
Preferred Qualifications:
- Experience in facility, utilities, and equipment qualification.
- Experience across the product development and commercialization lifecycle.
- Technical expertise in sterile pharmaceutical isolator technology, combination product, and medical devices.
This role will be expected to be on site for 80% of the work week, with exception of one day remote per week. In addition, the role will be required to be on site to perform Essential Duties and Responsibilities when physical activities are being performed on site.
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