Senior Quality Specialist

Kelly Science, Engineering, Technology & Telecom; Princeton (NJ); On-site; USD 100,000 - 140,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom seeks an experienced QA auditor responsible for GLP compliance and quality system oversight. The role conducts audits, supports regulatory inspections, and drives investigations and CAPA across CRO and bioanalytical settings.

The candidate will plan and execute risk-based audits, contribute to QMS enhancements, and improve audit methods and tools to sustain inspection readiness and continuous quality improvement.

Qualifications

• 8 years of solid GLP experience
• Experience in GLP study audit, vendor audit and facility audit
• Experience working for CRO companies and bioanalytical laboratories
• Experience developing an audit schedule and annual audit plan

Responsibilities

• Independently plan, conduct, document, and follow up on study, facility, process, system, and vendor audits. Support regulatory inspections and sponsor audits, ensuring ongoing inspection readiness.
• Lead or support investigations into deviations, non-compliances, and quality issues, including root-cause analysis and CAPA follow-up.
• Conduct risk assessments and provide quality guidance to support compliance and operational decisions.
• Own and develop an assigned QA focus area, such as Vendor Qualifications, Process Audits, or Continuous Improvement.
• Support the development, maintenance, and continuous improvement of the QMS.
• Improve audit methodologies, tools, and processes to enhance QA effectiveness.

Skills

GLP experience

Education

Degree in Science or related field

Job description

Responsible for ensuring compliance with GLP requirements, applicable regulatory guidelines, and internal quality systems. The role independently conducts complex audits, supports regulatory inspections, leads quality investigations, and drives continuous improvement.

Key Responsibilities

• Independently plan, conduct, document, and follow up on study, facility, process, system, and vendor audits. Support regulatory inspections and sponsor audits, ensuring ongoing inspection readiness.
• Lead or support investigations into deviations, non-compliances, and quality issues, including root-cause analysis and CAPA follow-up.
• Conduct risk assessments and provide quality guidance to support compliance and operational decisions.
• Own and develop an assigned QA focus area, such as Vendor Qualifications, Process Audits, or Continuous Improvement.
• Support the development, maintenance, and continuous improvement of the QMS.
• Improve audit methodologies, tools, and processes to enhance QA effectiveness.

Requirement:

• Degree in Science or related field
• 8 years of solid GLP experience, required
• Experience in GLP study audit, vendor audit and facility audit
• Experience working for CRO companies and bioanalytical laboratories
• Experience developing an audit schedule and annual audit plan