Quality Assurance Manager: Sterile Manufacturing & Compliance

Afton Scientific. LLC; Charlottesville (VA); On-site; USD 110,000 - 160,000; Full time

Job summary

Afton Scientific LLC in Charlottesville, VA seeks a Quality Assurance Manager to lead quality oversight for sterile manufacturing operations, ensuring compliance with FDA regulations, EU GMP, and Annex 1. You will review batch records, drive CAPA and deviation investigations, and support audits while partnering with manufacturing, QA, and regulatory affairs to uphold aseptic processing standards.

This on-site role requires a Bachelor’s degree in biology or related field, hands-on GMP experience,

Qualifications

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

Responsibilities

• Lead quality oversight for sterile and non‑sterile manufacturing activities.
• Review batch records and supporting documentation for data integrity.
• Drive deviation investigations and implement CAPAs.
• Review and approve SOPs, protocols, and validation documentation.
• Ensure personnel qualification and training for aseptic operations.
• Support internal and external audits and regulatory inspections.
• Collaborate with Manufacturing, QA, and Regulatory Affairs on quality standards.

Skills

FDA regulations knowledge

Leadership

Problem-solving

Communication

Training

Education

Bachelor’s degree in biology or related field

Tools

eQMS

Job description

Afton Scientific LLC in Charlottesville, VA seeks a Quality Assurance Manager to lead quality oversight for sterile manufacturing operations, ensuring compliance with FDA regulations, EU GMP, and Annex 1. You will review batch records, drive CAPA and deviation investigations, and support audits while partnering with manufacturing, QA, and regulatory affairs to uphold aseptic processing standards.

This on-site role requires a Bachelor’s degree in biology or related field, hands-on GMP experience,