QA Operations Associate I — GMP Quality & Compliance

American Regent, Inc.; New Albany (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent, Inc. in Ohio seeks a Quality Assurance Associate focused on ensuring GMP compliance across packaging lines and inspection rooms.

You will perform verifications, AQL inspections, and release of components and materials, while maintaining strict adherence to SOPs and regulatory requirements. The role requires the ability to work independently in a FDA-regulated environment, strong communication skills, and proficiency with Word and Excel.

Qualifications

• High School Diploma or GED required; Associates or Bachelor's degree preferred.
• Minimum 1 year in an FDA-regulated environment or similarly regulated area.
• Proficient in Word and Excel; strong organizational and communication skills.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification.
• Conduct accurate verifications and checks as well as accurate process inspections.
• Identify out of specification product, ensuring segregation and escalation as required.
• Ensure all work is performed and documented in accordance with SOPs and cGMP.
• Support product shipping activities and perform quality-related oversight and verifications.

Skills

GMP knowledge

cGMP

Documentation

Microsoft Excel

Team player

Education

High School Diploma

Associates or Bachelor's degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

American Regent, Inc. in Ohio seeks a Quality Assurance Associate focused on ensuring GMP compliance across packaging lines and inspection rooms.

You will perform verifications, AQL inspections, and release of components and materials, while maintaining strict adherence to SOPs and regulatory requirements. The role requires the ability to work independently in a FDA-regulated environment, strong communication skills, and proficiency with Word and Excel.