Quality Assurance Engineer
6 days ago
About Civica Rx: 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.
Estimated salary for this role is between $90,000 and $130,000 per year.
Job DescriptionThe Quality Assurance Engineer 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.
Responsibilities include maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and regulatory requirements.
This includes generating, reviewing, and approving policies, procedures, reports, and other records necessary to provide quality oversight of our Engineering functions.
- Ensure the site's quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.
- Provide quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure expert advice and technical support on all quality-related matters is provided.
Essential duties and responsibilities also include:
- Supporting and ensuring compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
- Implementing and overseeing quality processes and systems across the product lifecycle.
- Providing quality review and support for calibration and maintenance programs and ensuring they are run in accordance with GMP regulation.
Basic qualifications and capabilities include:
- 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.
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