Quality Systems Specialist (223)

Civica Rx • Petersburg, VA

3d • Onsite

About The Position

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 of the position include, but are not limited to, supporting the execution, coordination, and continuous improvement of site Quality Systems and Compliance across multiple quality system functions. In a cross-trained team environment, the Quality Systems Specialist will contribute to processes including Change Control, deviations, investigations, CAPA, self-inspection, supplier quality, complaints, and other quality system activities, as needed. This role is essential to maintaining compliance with applicable regulatory standards, including current Good Manufacturing Practices, and to supporting inspection readiness and the reliable supply of quality medicines to patients.

Requirements

• Bachelor’s Degree in scientific discipline a minimum of 4+ years of combined technical experience in a GMP related field within a pharmaceutical, biologics, or medical device manufacturing facility.
• Experience with Quality systems and demonstrated working knowledge in areas such as material/process controls, supplier quality management, audits, change control, deviation, CAPA, Management Review.
• Experience with cGMPs and Quality System regulatory requirements.
• Experience with Quality computerized system applications (e.g., Veeva, Deacom) or similar systems.
• Works on multiple assignments in collaboration with various department system owners.
• Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.
• Ability to communicate and work independently with scientific/technical personnel.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Strong organization, and execution skills with attention to detail.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Responsibilities

• 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.
• Continue building functional and technical expertise across quality systems to support team flexibility, process consistency, and business needs.
• Promote a culture of quality, safety, compliance, and continuous improvement in all activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level