Senior Quality Specialist - QMS & Compliance Leader

Kelly Science, Engineering, Technology & Telecom; Cincinnati (OH); On-site; USD 90,000 - 115,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom in Cincinnati, OH seeks a Senior Quality Specialist to oversee the QMS and ensure cGMP compliance across QA operations. This hands-on role reports to the Head of Quality and drives continuous improvement in a regulated setting.

The ideal candidate will lead document control, training programs, internal audits, CAPA coordination, and investigations while supporting regulatory inspections and quality metrics development.

Qualifications

• Minimum 5 years of Quality Assurance experience in pharma/biotech/CDMO or regulated industry.
• Strong knowledge of cGMP, FDA quality requirements and GDP.
• Experience with Document Control, CAPA, Change Control, Deviations.
• Proven ability to write clearly and manage documentation.
• Proficiency with Microsoft Office and electronic eQMS.

Responsibilities

• Lead development, implementation and continuous improvement of the QMS.
• Oversee creation, approval, distribution, control and archival of cGMP docs.
• Administer and maintain training programs for onboarding and GMP training.
• Review stability studies, method validation and investigation reports.
• Lead internal audits and support inspections; prepare audit responses and CAPA.
• Investigate deviations and OOS results; ensure timely resolution.
• Develop and monitor quality metrics to identify improvement opportunities.
• Ensure compliance with FDA, ICH and applicable cGMP regulations.
• Provide QA oversight for laboratory and manufacturing activities.

Skills

Document Control

CAPA

Change Control

Deviations

Internal audits

Training management

Quality metrics

Regulatory compliance

Process improvement

Education

Bachelor's or Master's in Chemistry / Microbiology / Pharmaceutical Sciences / Biology

Tools

Microsoft Office

eQMS

Job description

Kelly Science, Engineering, Technology & Telecom in Cincinnati, OH seeks a Senior Quality Specialist to oversee the QMS and ensure cGMP compliance across QA operations. This hands-on role reports to the Head of Quality and drives continuous improvement in a regulated setting.

The ideal candidate will lead document control, training programs, internal audits, CAPA coordination, and investigations while supporting regulatory inspections and quality metrics development.