QA Operations Leader: Sterile Fill-Finish

BioSpace; Petersburg (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Civica, Inc. in Petersburg, VA, seeks a Quality Assurance Supervisor-Operations to lead site quality systems for sterile fill-finish manufacturing and ensure regulatory compliance. The role oversees batch records, deviations, and CAPA, driving quality excellence and safety across all operations.

The role requires 5+ years in quality/CGMP within pharma, with sterile injectable manufacturing experience, and strong leadership and communication skills to support FDA inspections and site readiness.

Qualifications

• Bachelor’s degree in a scientific discipline with 5+ years CGMP experience in the pharmaceutical industry.
• Experience in sterile injectable manufacturing and packaging operations.
• Proven project management, organization, and shop floor execution.
• Participation and leading activities to support regulatory agency inspections.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications.

Responsibilities

• Establish and maintain the site’s quality systems related to manufacturing operations.
• Promote a quality mindset and quality excellence across activities.
• Promote a safety mindset for all operational activities.
• Oversee operational quality aspects of sterile fill-finish manufacturing including batch record review and disposition.
• Ensure compliance with FDA, DEA, Civica requirements.
• Develop and maintain SOPs and training for QA shop-floor support.
• Provide leadership and training to shop floor personnel.
• Maintain knowledge of FDA and Civica requirements and participate in risk analysis.
• Support, review and approve equipment qualifications and process transfers.
• Manage quality processes across the product lifecycle including CAPA, deviations, and investigations.

Skills

Quality Assurance

Project management

Communication skills

Self-motivated

Education

Bachelor’s degree in a scientific discipline

Tools

LIMS

Electronic systems

Job description

Civica, Inc. in Petersburg, VA, seeks a Quality Assurance Supervisor-Operations to lead site quality systems for sterile fill-finish manufacturing and ensure regulatory compliance. The role oversees batch records, deviations, and CAPA, driving quality excellence and safety across all operations.

The role requires 5+ years in quality/CGMP within pharma, with sterile injectable manufacturing experience, and strong leadership and communication skills to support FDA inspections and site readiness.