QA Specialist, I

QA Specialist I will oversee batch record reviews, lot disposition, and quality system administration for clinical and commercial pharmaceutical products. The role involves deviation management, investigation oversight, CAPA coordination, and cross-functional collaboration to ensure cGMP compliance and regulatory standards at a Bedford, NH facility.

Responsibilities

• Review and approve batch documentation for clinical and commercial product release ensuring cGMP and regulatory compliance
• Manage deviation, investigation, and CAPA programs including review, approval, and tracking for timely closure
• Develop, review, and approve quality system procedures, specifications, test methods, and change control documentation
• Lead quality improvement projects and serve as QA representative on cross-functional teams for tech transfer and process validation
• Coordinate with internal and external stakeholders on compliance matters and regulatory inspection readiness

Requirements

• Root cause analysis, technical writing, and quality investigation experience
• Knowledge of laboratory/production equipment and IQ/OQ/PQ protocols
• FDA regulations expertise (21 CFR Parts 210, 211, 820) and ICH familiarity
• Risk management tools proficiency (FMEA, HACCP, PHA) and ICH Q9 knowledge
• Bachelor's degree in relevant science discipline; 5-7 years pharma/biotech experience; 3+ years QA operations supporting late-stage clinical/commercial production
• MS Office proficiency (Word, Excel, Access, Visio) and excellent written/verbal communication
• Strong organizational skills, risk-based decision-making ability, and self-directed work style