Quality Project Lead: GMP & CAPA Expert

ThermoFisher Scientific; Cincinnati (OH); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Annual bonus

Healthcare

Job summary

Thermo Fisher Scientific in Cincinnati seeks a Quality Specialist III to uphold regulatory compliance, drive continuous improvement of quality systems, and partner with cross-functional teams to investigate issues and implement corrective actions. The role emphasizes CAPA, audits, and documentation.

The position requires an advanced degree or a bachelor's with substantial experience in a regulated environment, with strong analytical and writing skills and a collaborative mindset.

Qualifications

• Advanced degree plus 3 years of relevant experience or a bachelor's degree plus 5 years in a regulated setting.
• Degree in Life Sciences, Engineering, Chemistry, Biology, or related technical field preferred.
• Experience in pharma/biotech or medical device environments is advantageous.

Responsibilities

• Investigate quality issues using root cause analysis and appropriate investigation techniques.
• Manage and support CAPA, deviation, and change control processes.
• Conduct and host internal and external audits and support regulatory inspections.
• Author and maintain SOPs, investigation reports, and other quality documentation.
• Analyze quality data, trends, and metrics to identify opportunities for improvement.
• Apply risk assessment methodologies and continuous improvement tools.
• Collaborate with and guide cross-functional teams in implementing effective corrective actions.
• Support ongoing compliance with GMP/GxP regulations, ISO standards, and applicable quality system requirements.

Skills

GMP/GxP knowledge

Statistical analysis

Technical writing

Problem solving

Verbal and written communication

Independent work

Cross-functional collaboration

Quality systems knowledge

Education

Advanced degree + 3 yrs

Bachelor's +5 yrs

Life Sciences/Engineering/Chemistry/ Biology field

Tools

TrackWise

Document control systems

Microsoft Office

Job description

Thermo Fisher Scientific in Cincinnati seeks a Quality Specialist III to uphold regulatory compliance, drive continuous improvement of quality systems, and partner with cross-functional teams to investigate issues and implement corrective actions. The role emphasizes CAPA, audits, and documentation.

The position requires an advanced degree or a bachelor's with substantial experience in a regulated environment, with strong analytical and writing skills and a collaborative mindset.