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Thermo Fisher Scientific is seeking a Quality Assurance Specialist II for its Millersburg, PA location. The role involves managing and improving a risk-based Quality Management System, conducting internal audits, and ensuring compliance with quality standards.
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Job Summary
This role is instrumental in driving year-over-year double-digit growth through support of critical quality and operational initiatives.
The position requires establishing and managing a risk-based internal Quality Management System audit program while conducting internal audits.
Employees will maintain oversight of the site Environmental Monitoring Program including surveillance of ISO 7 & 8 suites and compendial testing.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific is seeking a Quality Assurance Specialist II for its Millersburg, PA location. The role involves managing and improving a risk-based Quality Management System, conducting internal audits, and ensuring compliance with quality standards.
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Skills & Requirements
Must-have
Good Manufacturing Practices GMP adherence
Internal audit program management
CAPA and TrackWise record management
Cleanroom environmental monitoring
ISO 13485 knowledge application
Nice-to-have
Strong investigative critical thinking skills
Ability to influence without direct authority
Proficiency with statistical tools Minitab
Positive attitude with strong interpersonal skills
Experience developing and implementing procedures
Key Requirements
Minimum 2+ years experience in Quality Management System environment