Quality Project Lead
$31,200–$31,200 year
On-siteCincinnati, Ohio, United States
Job Summary
Investigate quality issues using root cause analysis and manage CAPA, deviation, and change control processes. Conduct and host internal and external audits while supporting regulatory inspections. Author SOPs, investigation reports, and other quality documentation to maintain compliance with GMP/GxP regulations and ISO standards. Analyze quality data and trends to identify improvement opportunities, applying risk assessment methodologies and continuous improvement tools. Collaborate with cross-functional teams to implement corrective actions and foster a culture of quality excellence. This role supports the Cincinnati oral solid drug manufacturing site, enabling the development of solutions for global health challenges.
Required Qualifications
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, including a drug screening
- Advanced degree plus 3 years of relevant experience, or bachelor's degree plus 5 years of relevant experience
- Degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field
- Quality assurance and/or quality control experience within a regulated industry; pharmaceutical, medical device, or biotech experience
- Experience with quality management systems, CAPA, deviation management, and change control
- Demonstrated expertise in root cause analysis, investigations, and corrective action implementation
- Experience conducting and hosting internal/external audits and regulatory inspections
- Ability to work independently and collaborate with or guide cross-functional teams
- Proficiency with quality systems software such as TrackWise and document control systems, as well as Microsoft Office
- Knowledge of risk assessment methodologies and continuous improvement tools
- Ability to work in manufacturing environments and comply with PPE requirements as needed
- Strong knowledge of GMP/GxP regulations, ISO 9001/13485, and other relevant quality system requirements
- Proficiency in statistical analysis, data trending, and quality metrics reporting
- Strong technical writing skills for SOPs, investigation reports, and other quality documentation
- Advanced problem-solving skills with strong attention to detail
- Excellent verbal and written communication and strong interpersonal skills
- Quality focused
- Collaborative
- Accountable
- Analytical problem solver
- Effective communicator
- Continuous improvement mindset
Desired Qualifications
- Client-facing experience preferred
- Project management experience preferred
- Experience with quality management systems, CAPA, deviation management, and change control
- Demonstrated expertise in root cause analysis, investigations, and corrective action implementation
- Experience conducting and hosting internal/external audits and regulatory inspections
- Experience with quality management systems, CAPA, deviation management, and change control
- Experience with quality management systems, CAPA, deviation management, and change control
- Demonstrated expertise in root cause analysis, investigations, and corrective action implementation
- Experience conducting and hosting internal/external audits and regulatory inspections
- Client-facing experience preferred
- Project management experience preferred
- Experience with quality management systems, CAPA, deviation management, and change control
- Demonstrated expertise in root cause analysis, investigations, and corrective action implementation
- Experience conducting and hosting internal/external audits and regulatory inspections
- Client-facing experience preferred
- Project management experience preferred
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