GMP Quality Systems & Compliance Specialist

Civica; 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 support and improve the site’s quality systems and regulatory compliance for sterile injectable medicines.

You will contribute across change control, deviations, CAPA, audits, supplier quality, and complaints to ensure cGMP adherence and inspection readiness. The role requires a scientific degree and 4+ years of GMP experience, with proficiency in quality systems and related software.

Qualifications

• Bachelor’s Degree in a scientific discipline with 4+ years GMP experience.
• Experience with Quality systems and material/process controls.
• Familiar with cGMPs and regulatory requirements.
• Experience with Quality computerized systems (e.g., Veeva, Deacom).

Responsibilities

• Support the execution, coordination, and continuous improvement of site Quality Systems and Compliance in a cross-trained team environment.
• Perform activities across multiple quality system functions including change control, deviations/investigations, CAPA, internal audit/self-inspection, supplier quality, complaints.
• Review, edit, coordinate, and maintain quality system records to ensure compliance with cGMP and internal procedures.
• Facilitate cross-functional meetings and follow-up activities to drive progress on quality system deliverables.
• Monitor quality system activities for timeliness, completeness, and compliance, escalating issues as needed.
• Analyze quality system metrics to identify issues and support continuous improvement.

Skills

Quality systems

Change control

Deviations

CAPA

Internal audits

Supplier quality

Regulatory compliance

Documentation

Cross-functional

Education

Bachelor's degree in science

Tools

Veeva

Deacom

Job description

Civica, Inc. in Petersburg, VA, is seeking a Quality Systems Specialist to support and improve the site’s quality systems and regulatory compliance for sterile injectable medicines.

You will contribute across change control, deviations, CAPA, audits, supplier quality, and complaints to ensure cGMP adherence and inspection readiness. The role requires a scientific degree and 4+ years of GMP experience, with proficiency in quality systems and related software.