GMP Quality Systems Specialist

Civica Rx; Petersburg (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

Civica, Inc. in Petersburg, Virginia, is seeking a Quality Systems Specialist to support and improve site quality systems across multiple functions.

You will work in a cross-trained team to handle change control, deviations, CAPA, internal audits, supplier quality, and complaints, ensuring cGMP compliance and inspection readiness. The role emphasizes cross-functional collaboration, documentation control, and continuous improvement to ensure reliable supply of quality medicines to patients at the

Qualifications

• 4+ years in GMP pharmaceutical, biologics, or medical device manufacturing.
• Experience with quality systems and areas such as change control, deviations, CAPA.
• Knowledge of cGMPs and regulatory requirements.
• Experience with quality computerized systems (e.g., Veeva, Deacom).
• Strong communication and cross-functional collaboration.

Responsibilities

• Support execution and continuous improvement of site Quality Systems.
• Contribute to change control, deviations/investigations, CAPA, audits, supplier quality, and complaints.
• Maintain quality system records to ensure compliance with cGMP and internal procedures.
• Support inspection readiness and regulatory readiness.
• Facilitate cross-functional meetings and follow-up activities to drive progress.
• Monitor quality system activities for timeliness and compliance.
• Analyze quality metrics to support routine reporting and improvements.
• Provide guidance and knowledge sharing across the Quality Systems team.
• Build collaborative relationships across departments to promote quality processes.

Skills

GMP compliance

Quality systems

Documentation control

Audits

Cross-functional collaboration

Tools

Veeva

Deacom

Job description

Civica, Inc. in Petersburg, Virginia, is seeking a Quality Systems Specialist to support and improve site quality systems across multiple functions.

You will work in a cross-trained team to handle change control, deviations, CAPA, internal audits, supplier quality, and complaints, ensuring cGMP compliance and inspection readiness. The role emphasizes cross-functional collaboration, documentation control, and continuous improvement to ensure reliable supply of quality medicines to patients at the