QA Operations Lead – Sterile Fill-Finish (1st/2nd)

RXinsider LTD.; Petersburg (VA); On-site; USD 90,000 - 135,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Civica, Inc. seeks a Quality Assurance Supervisor-Operations at its Petersburg, Virginia site to drive QA systems for sterile manufacturing and ensure CGMP regulatory compliance. You will oversee batch release, deviations, and training while aligning with FDA expectations for new medications.

The role requires 5+ years in pharmaceutical QA, strong project management, and leadership to ensure high-quality, compliant operations in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years in pharma QA/CGMP.
• Experience with sterile injectable manufacturing and packaging operations.
• Strong project management and communication skills; regulatory inspections experience.

Responsibilities

• Establish and maintain QA systems for sterile manufacturing operations.
• Lead quality review, batch disposition, and deviation investigations.
• Support regulatory compliance and inspections readiness.
• Provide leadership to shop-floor QA staff and training programs.

Skills

Quality Assurance

Project management

Regulatory inspections

CGMP knowledge

Education

Bachelor's degree in a scientific discipline

Tools

Quality management software

Job description

Civica, Inc. seeks a Quality Assurance Supervisor-Operations at its Petersburg, Virginia site to drive QA systems for sterile manufacturing and ensure CGMP regulatory compliance. You will oversee batch release, deviations, and training while aligning with FDA expectations for new medications.

The role requires 5+ years in pharmaceutical QA, strong project management, and leadership to ensure high-quality, compliant operations in a fast-paced environment.