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Petersburg, United States BioSpace, Inc. Full timeAbout BioSpace, Inc.Civica 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 provide essential sterile injectable medications and combination products to patients in need.Job Description:The Quality...
Quality Assurance Specialist
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.
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, and by partnering with healthcare systems and pharmacies to make these medications available at a lower cost.
Job SummaryWe are seeking a Quality Assurance Engineer to join our team at our Petersburg, Virginia site. As a Quality Assurance Engineer, you will be responsible for maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and Civica compliance requirements.
Key Responsibilities- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality-related matters is provided to the site.
- Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
- Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
- Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
- Provide quality review and support for calibration and maintenance programs and ensure they are run in accordance with GMP regulation.
- Bachelor's degree in a scientific discipline with a minimum of 4 years Quality/cGMP experience in the pharmaceutical industry.
- Experience in facility and equipment qualification, process validation, LIMS systems, and calibration and maintenance programs.
- 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.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.
