Senior QA Compliance & Validation Specialist

American Regent, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

American Regent, Inc. is seeking a QA Technical Services Specialist III to lead technical and quality compliance reviews under cGMP guidelines.

The role involves auditing critical equipment, utilities, analytical data, and validation reports across laboratory and production environments, with minimal supervision. The incumbent will support QA project teams, manage regulatory inspections, write SOPs, and serve as a regulatory cGMP resource.

Qualifications

• B.S. or M.S. in Life Sciences, Chemistry, Pharmaceutical Science or related field required.
• Minimum of five years pharmaceutical experience in QA, Regulatory Compliance, cGMP Compliance Auditing, or related cGMP activities.
• Strong analytical skills, attention to detail and adherence to all procedures and company policies.
• Working knowledge of cGMP regulations, cGxP and associated Quality Systems activities.
• Able to travel domestically as needed.

Responsibilities

• Work closely with Validation, Engineering, Production R&D, Operations and Quality Systems to ensure qualification/recertification expectations are met.
• Review GMP documents using Quality Risk Management and advise authors on discrepancies or deviations.
• Pro-actively identify, manage, and communicate potential quality risks with follow-up actions.
• Ensure all work complies with company policies, cGMP, and safety requirements.
• Review Calibration, Maintenance and preventive maintenance records (BMRAM) and related activities.
• Support regulatory inspections and on-site cGMP audits by external providers.

Skills

QA Auditing

Regulatory Compliance

cGMP

Quality Systems

Investigation & CAPA

GxP Knowledge

Education

Bachelor's or Master's in Life Sciences/ Chemistry/ Pharmaceutical Science

Tools

BMRAM

Document management software

Asset management software

Job description

American Regent, Inc. is seeking a QA Technical Services Specialist III to lead technical and quality compliance reviews under cGMP guidelines.

The role involves auditing critical equipment, utilities, analytical data, and validation reports across laboratory and production environments, with minimal supervision. The incumbent will support QA project teams, manage regulatory inspections, write SOPs, and serve as a regulatory cGMP resource.