QA Lead - Sterile Fill/Finish Operations

BioSpace; Petersburg (VA); On-site; USD 95,000 - 130,000; Full time

Job summary

The Quality Assurance Supervisor - Operations at Civica, Inc. will join the Petersburg, Virginia site to lead quality and compliance for sterile fill-finish manufacturing of generic medications. This role focuses on CGMP processes, batch record review, deviations management, and regulatory readiness.

You will mentor shop-floor staff, develop SOPs, support FDA inspections, and drive continuous improvement across quality systems from build-out through ongoing operations in a fast-paced environment.

Qualifications

• Minimum 5+ years of QA/CGMP experience in pharmaceuticals.
• Experience in sterile injectable manufacturing preferred.
• Inspections by regulatory agencies experience desirable.

Responsibilities

• Establish and maintain quality systems for sterile manufacturing operations.
• Lead shop-floor quality oversight, batch record review, and deviations.
• Ensure compliance with FDA, CGMP, and DEA requirements.
• Develop, review, and approve SOPs and training materials.
• Support regulatory inspections and continuous improvement.

Skills

Project management

Quality assurance

Regulatory inspections

Written communication

Autonomous work style

Education

Bachelor's degree in a scientific discipline

Job description

The Quality Assurance Supervisor - Operations at Civica, Inc. will join the Petersburg, Virginia site to lead quality and compliance for sterile fill-finish manufacturing of generic medications. This role focuses on CGMP processes, batch record review, deviations management, and regulatory readiness.

You will mentor shop-floor staff, develop SOPs, support FDA inspections, and drive continuous improvement across quality systems from build-out through ongoing operations in a fast-paced environment.