Senior QA Compliance & Validation Specialist

American Regent, Inc.; New Albany (OH); Hybride; USD 95 000 - 125 000; Plein temps

Résumé du poste

American Regent, Inc. is seeking a QA Technical Services Specialist III to lead technical reviews and audits for cGMP documentation.

The role collaborates with Validation, Engineering, Production R&D, and Operations to ensure qualification standards are met and regulatory requirements are upheld. You will help manage quality risks, draft and revise SOPs, and support regulatory inspections with minimal supervision.

Qualifications

• Five years of pharmaceutical QA or regulatory compliance experience.
• Strong analytical skills and attention to detail.
• Working knowledge of cGMP regulations and related QA systems.
• Willingness to travel domestically.

Responsabilités

• Collaborate with cross-functional teams (Validation, Engineering, Production R&D) to meet qualification/ re-qualification expectations.
• Review GMP documents using Quality Risk Management and guide authors on discrepancies.
• Identify and manage quality risks and ensure follow-up actions.
• Ensure work complies with SOPs, policies, cGMP, and safety requirements.
• Review calibration and maintenance records (BMRAM, etc.) and support inspections.

Connaissances

Analytical skills

Attention to detail

Communication skills

GMP knowledge

Travel allowed

Formation

Bachelor's or Master's in Life Sciences

Outils

Asset management software

BMRAM

Document management software

Description du poste

American Regent, Inc. is seeking a QA Technical Services Specialist III to lead technical reviews and audits for cGMP documentation.

The role collaborates with Validation, Engineering, Production R&D, and Operations to ensure qualification standards are met and regulatory requirements are upheld. You will help manage quality risks, draft and revise SOPs, and support regulatory inspections with minimal supervision.