Quality Systems Specialist (223)

About the role

The Quality Systems Specialist will join Civica, Inc. (“Civica”) at the Petersburg, Virginia site, bringing knowledge and experience in service to patients and in support of excellence in quality and compliance. The Petersburg site serves as Civica’s fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities

• Supporting the execution, coordination, and continuous improvement of site Quality Systems and Compliance across multiple quality system functions.
• In a cross-trained team environment, contributing to processes including Change Control, deviations, investigations, CAPA, self-inspection, supplier quality, complaints, and other quality system activities, as needed.
• Maintaining compliance with applicable regulatory standards, including current Good Manufacturing Practices, and supporting inspection readiness and the reliable supply of quality medicines to patients.
• Support the execution, coordination, and continuous improvement of site Quality Systems and Compliance within a cross-trained team environment, serving as a primary contact or subject matter resource for assigned areas as needed.
• Perform and support activities across multiple quality system functions, including but not limited to change control, deviations/investigations, CAPA, internal audit/self-inspection, supplier quality, complaints, and related quality processes.
• Review, edit, coordinate, and maintain quality system records and documentation to ensure compliance with cGMP, regulatory, and internal procedure requirements.
• Facilitate or support cross-functional meetings and follow-up activities to help drive timely progress and completion of assigned quality system deliverables.
• Monitor assigned quality system activities for timeliness, completeness, and compliance, escalating issues as appropriate.
• Track, trend, and analyze quality system metrics to support routine reporting, identify issues, and contribute to continuous improvement efforts.
• Apply applicable procedures, regulatory requirements, and quality standards to support consistent execution of quality system processes and resolution of routine and moderately complex issues.
• Build collaborative working relationships across departments to provide day-to-day guidance and promote understanding of quality system requirements and standard processes.
• Author, revise, and support implementation of procedures, work practices, and other controlled documents within area of responsibility.
• Participate in inspection readiness activities, internal audits/self-inspections, supplier quality activities, and regulatory inspection support as needed.
• Support supplier qualification, monitoring, and related quality activities, including participation in investigations, audit CAPA follow-up, and quality agreement support, as applicable.
• Support the management of complaints and pharmacovigilance-related records and activities, as applicable, in accordance with site procedures and health authority requirements.
• Identify risks, raise quality concerns appropriately, and work collaboratively with cross-functional partners to implement practical, compliant, and risk-based solutions.
• Provide informal guidance, training, and knowledge sharing to peers and new team members across the Quality Systems team.