Not specified; performance-related bonus available...
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Cgmp regulatory compliance expertise
Ich q9 quality risk management principles
Fmea and haccp risk assessment facilitation
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Lonza Group is seeking a QA Specialist IV in Quality Risk Management based in Portsmouth, NH. The role involves ensuring compliance with cGMP regulations, facilitating risk assessments, and enhancing product quality and patient safety through risk management strategies.
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Job Summary
This role serves as a subject matter expert ensuring compliance with cGMP regulations by advancing the site-wide Quality Risk Management program.
The specialist partners cross-functionally to facilitate risk assessments using tools like FMEA, HACCP, and What-if analysis to drive product quality and patient safety.
Candidates will receive a comprehensive benefits package including performance-related bonuses, medical/dental/vision insurance, and 401(k) matching.
Matching Summary
Match Score: 75
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Lonza Group is seeking a QA Specialist IV in Quality Risk Management based in Portsmouth, NH. The role involves ensuring compliance with cGMP regulations, facilitating risk assessments, and enhancing product quality and patient safety through risk management strategies.
**
Salary
Not specified; Performance-related bonus available; Medical, dental, vision, 401(k), life, disability, PTO included
Skills & Requirements
Must-have
cGMP regulatory compliance expertise
ICH Q9 Quality Risk Management principles
FMEA and HACCP risk assessment facilitation
Cross-functional collaboration on quality systems
Data integrity adherence in all activities
Nice-to-have
ASQ CQE or CQA certification
Formal risk management training background
Experience with global quality initiatives
Ability to influence diverse organizational levels
Continuous improvement initiative leadership
Key Requirements
Bachelor's degree in Life Sciences or Engineering
5-8+ years of GMP-regulated environment experience
Strong working knowledge of FDA and EMA regulations
Proven experience leading risk assessments
Certification in Quality (e.g., ASQ CQE/CQA) preferred