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Associate Director, Quality Assurance
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Petersburg, United States Civica Rx Full timeAbout Civica Rx: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 mission is to ensure that patients have access to affordable, high-quality medications.Job Summary:We are seeking an experienced Associate Director, Quality Assurance to join our team at...
Quality Assurance Engineer
2 months 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.
The organization is led by an experienced team of healthcare and pharmaceutical industry leaders, with a mission to ensure that quality generic medications are accessible and affordable to everyone.
Civica Rx has made significant progress in achieving its mission, with over 55 health systems joining the organization, representing over 1,500 hospitals and one-third of all U.S. hospital beds.
The organization has 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.
Civica Rx recently announced plans to expand its mission, via a unit called CivicaScript, to manufacture and distribute insulins at significantly lower prices than those currently on the market.
Job DescriptionThe Quality Assurance Engineer will join the Civica Rx Quality organization 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 Civica Rx's new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
The Quality Assurance Engineer will be responsible for maintaining quality systems and oversight to ensure the validation/qualification and operation of computerized systems meet cGMP and Civica Rx compliance requirements.
Responsibilities will also include generating, reviewing, and approving policies, procedures, reports, and other records necessary to provide quality oversight of Civica Rx 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, including change control, CAPA, deviations, and investigations.
- Participate or lead in quality risk analysis.
- 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.
- Experience in facility, utilities, and equipment qualification.
- Experience across the product development and commercialization lifecycle, including change management and associated implementation strategies.
- 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.
