QA Operations Lead, Sterile Fill-Finish

Civica; Petersburg (VA); On-site; USD 110,000 - 150,000; Full time

Job summary

Civica, Inc. seeks a Quality Assurance Supervisor - Operations for its Petersburg, Virginia site, a new fill-finish facility delivering generic sterile injectables. The role focuses on establishing and maintaining QA systems to ensure manufacturing compliance and patient safety.

You will lead shop floor quality activities, review batch records, and support training while ensuring CGMP, FDA and DEA requirements are met. Travel is limited.

Qualifications

• Bachelor’s degree in a scientific discipline with 5+ years of QA/CGMP experience in the pharmaceutical industry.
• Experience in sterile injectable manufacturing and packaging operations.
• Experience supporting regulatory agency inspections required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

Responsibilities

• Establish and maintain the site’s quality systems related to manufacturing operations to enable reliable supply of quality generic medications to patients.
• Lead shop-floor quality activities and documentation to support manufacturing processes.
• Ensure compliance with FDA, CGMP and DEA requirements for the site.
• Support equipment qualifications and product/process transfers, including validation, from development and/or other sites.
• Provide leadership, direction, and training to ensure staff are qualified and operate safely.

Skills

Quality assurance

Project management

Regulatory inspections

Communication skills

Leadership experience

Education

Bachelor’s degree in a scientific discipline

Job description

Civica, Inc. seeks a Quality Assurance Supervisor - Operations for its Petersburg, Virginia site, a new fill-finish facility delivering generic sterile injectables. The role focuses on establishing and maintaining QA systems to ensure manufacturing compliance and patient safety.

You will lead shop floor quality activities, review batch records, and support training while ensuring CGMP, FDA and DEA requirements are met. Travel is limited.