Quality Assurance Engineer
1 week 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. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients.
Job DescriptionResponsibilities- Support 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 at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
- Generate, review and/or approve policies, procedures, reports, and other records necessary to provide quality oversight to ensure FDA requirements are met.
- 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.
- Participate in Quality Risk Management and analysis.
- 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.
- 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 including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, Annual Product Quality Review (APQR), and management notification.
- 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.
- Work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- 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.
- Participating in and leading activities that support regulatory agency inspections is required.
- 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.
- Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.
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