Hiring: Quality Assurance Manager Company: Afton Scientific, LLC Location: Charlottesville, VA Job Posted Time: 2026-09-03 10:40:43 Target Skills & Keywords : Quality Assurance, Regulatory Compliance, Risk Management, Root Cause Analysis About the job Experience: •25+ Years Building High-Performance Cultures Required Skills: •This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory compliance. Qualifications: •Bachelor’s degree in biology or related field •Strong working knowledge of FDA regulations, EU GMP, and Annex 1 •Proven working experience in lot release, deviation management, and CAPA systems •Excellent problem-solving, communication, and leadership skills. •In-depth knowledge of risk management principles (e.g., ICH Q9). •Demonstrated capacity to manage multiple priorities in a fast-paced environment. •Ensure operations are conducted in accordance with applicable •FDA regulations, EU GMP requirements, and Annex 1 guidance for both sterile and non‑sterile manufacturing activities •Review batch records and supporting documentation in accordance with approved procedures to ensure product quality and data integrity prior to disposition •Lead and support deviation investigations Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!