Quality Specialist

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

We are seeking an experienced Senior Quality Specialist to oversee and support the company's Quality Management System (QMS) and Quality Assurance operations. Reporting directly to the Head of Quality, this role is responsible for ensuring compliance with cGMP, regulatory requirements, and internal quality standards while driving continuous improvement initiatives across the organization.

The ideal candidate is a hands-on quality professional with experience in pharmaceutical, biotechnology, CDMO, or other regulated environments.

Key Responsibilities

• Lead the development, implementation, and continuous improvement of the company's Quality Management System (QMS).
• Oversee the creation, approval, distribution, control, and archival of cGMP documentation, including:
• SOPs, Technical reports, Batch records, Training records, Logbooks
• Controlled quality documentation
• Manage document control processes, including document change requests, revision control, approval workflows, and employee training.
• Administer and maintain the company's training program, including:
• New employee onboarding, Annual GMP training, Refresher training
• Job-specific training curricula, Training compliance records
• Review scientific documentation, including stability studies, method validation reports, and investigation reports.
• Lead internal quality audits and support customer and regulatory inspections.
• Prepare audit reports, coordinate responses, and oversee CAPA.
• Investigate deviations, nonconformances, and Out-of-Specification (OOS) results and ensure timely resolution.
• Develop and monitor quality metrics to evaluate QMS performance and identify opportunities for continuous improvement.
• Ensure compliance with FDA, ICH, and applicable cGMP regulations.
• Provide Quality Assurance oversight for laboratory and manufacturing activities.

Qualifications

• Bachelor's or Master's degree in Chemistry, Microbiology, Pharmaceutical Sciences, Biology, or a related scientific discipline.
• Minimum of 5 years of Quality Assurance experience within the pharmaceutical, biotechnology, CDMO, or other regulated industry.
• Strong knowledge of cGMP regulations, FDA quality requirements, Good Documentation Practices (GDP), and Pharmaceutical Quality Systems.
• Experience with:
• Document Control, CAPA, Change Control, Deviations
• OOS investigations, Internal audits, Training management
• Strong technical writing and documentation skills.
• Proficiency with Microsoft Office and electronic eQMS.