Quality Systems Specialist — GMP Compliance & CAPA

Civica, Inc.; Petersburg (VA); On-site; USD 85,000 - 120,000; Full time

Job summary

Civica, Inc. in Petersburg, VA, is seeking a Quality Systems Specialist to join our fill-finish facility focused on essential generic sterile injectable medications.

The role supports site Quality Systems, CAPA, audits, investigations, and supplier quality to ensure cGMP compliance and inspection readiness. Collaboration across departments is essential for timely, compliant quality deliverables.

Qualifications

• Bachelor’s degree in a scientific discipline with 4+ years GMP experience.
• Experience with quality systems such as change control, deviations, CAPA, audits.
• Familiarity with cGMPs and regulatory requirements.
• Experience with quality systems software (Veeva, Deacom).

Responsibilities

• Support execution, coordination, and continuous improvement of site Quality Systems and Compliance across multiple functions.
• Perform activities across change control, deviations/investigations, CAPA, internal audit/self-inspection, supplier quality, complaints.
• Review and maintain quality system records to ensure compliance with cGMP and internal procedures.
• Facilitate cross-functional meetings and ensure timely progress of quality deliverables.
• Monitor quality system activities for timeliness and compliance; escalate issues as needed.
• Track, trend, and analyze quality system metrics for routine reporting and improvements.

Skills

Quality systems

cGMP compliance

Documentation control

Audits

CAPA

Veeva/Deacom

Education

Bachelor's degree in scientific discipline

Tools

Veeva

Deacom

Job description

Civica, Inc. in Petersburg, VA, is seeking a Quality Systems Specialist to join our fill-finish facility focused on essential generic sterile injectable medications.

The role supports site Quality Systems, CAPA, audits, investigations, and supplier quality to ensure cGMP compliance and inspection readiness. Collaboration across departments is essential for timely, compliant quality deliverables.