QA Specialist V-Quality Risk Management
On-sitePortsmouth, New Hampshire, United States
Portsmouth, New Hampshire, United StatesOn-siteFull TimeSenior LevelBachelors DegreeEnterprise
Full TimeSenior LevelBachelors DegreeEnterprise
Job Summary
Lead cross-functional quality risk assessments and facilitate risk-based decision-making to support site projects and initiatives. Maintain and improve site risk registers and governance processes while reviewing assessments to ensure compliance with site procedures. Provide quality risk management expertise to Manufacturing, Quality Control, Engineering, and Technical Operations teams, driving continuous improvement of the site's Quality Risk Management program. Support audits, inspections, and regulatory readiness activities to strengthen site-wide quality culture and regulatory compliance.
Required Qualifications
- Bachelor's degree in Life Sciences or a related field
- Experience working in a GMP-regulated environment
- Knowledge of Quality Risk Management principles and risk assessment methodologies
- Strong analytical, problem-solving, and decision-making skills
- Excellent communication and facilitation skills
- Ability to manage multiple priorities and deliver results independently
- Strong collaboration and stakeholder management capabilities
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