Sterile QA Manager — FDA/GMP Compliance, Charlottesville

BioSpace; Charlottesville (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Afton Scientific in Charlottesville, VA is seeking a Quality Assurance Manager to lead quality oversight for sterile manufacturing, ensure FDA/EU GMP and Annex 1 compliance, and manage batch release and CAPA activities.

The role collaborates with production, QC, and engineering teams to sustain aseptic processing standards, drive continuous improvement, and support regulatory readiness.

Qualifications

• Bachelor's degree in biology or related field.
• Strong working knowledge of FDA regs, EU GMP, and Annex 1.
• Experience in lot release, deviation mgmt, and CAPA systems.
• Experience supporting regulatory inspections and audits (FDA/Client).
• Excellent problem-solving, communication, and leadership skills.

Responsibilities

• Ensure operations comply with FDA, EU GMP and Annex 1 guidance for sterile and non-sterile activities.
• Review batch records and supporting documentation prior to disposition.
• Lead deviation investigations with root-cause analysis and compliant resolutions.
• Develop, implement, and track CAPAs per quality system requirements.
• Review SOPs, protocols, and validation documents related to sterilization, aseptic filling, cleaning, and gowning.
• Ensure personnel qualification and training for aseptic operations are current and effective.
• Support audits and regulatory inspections; act as SME for sterile manufacturing and Annex 1 compliance.

Skills

Quality leadership

FDA/EU GMP knowledge

CAPA management

Deviation investigations

Data analysis

Education

Bachelor's degree in biology or related field

Tools

eQMS

Job description

Afton Scientific in Charlottesville, VA is seeking a Quality Assurance Manager to lead quality oversight for sterile manufacturing, ensure FDA/EU GMP and Annex 1 compliance, and manage batch release and CAPA activities.

The role collaborates with production, QC, and engineering teams to sustain aseptic processing standards, drive continuous improvement, and support regulatory readiness.