QA Operations Associate - GMP & Packaging Quality

American Regent, Inc.; New Albany (OH); Hybrid; USD 65,000 - 85,000; Full time

Job summary

American Regent, Inc. is seeking a QA-focused professional to ensure quality in assigned areas by executing site policies, procedures, programs, and work instructions in a FDA-regulated environment.

You will perform verifications, packaging inspections, AQL checks, and product release activities while maintaining cGMP and safety standards. The role requires strong organizational and communication skills and flexibility to work overtime as needed.

Qualifications

• High School Diploma or GED required; Associates or Bachelor's Degree preferred.
• Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational, interpersonal and communication skills are required.
• Ability to take feedback constructively and work in a team environment; overtime as needed.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification.
• Conduct accurate verifications and checks as well as accurate process inspections.
• Perform accurate packaging AQL inspections.
• Identify out of specification product with segregation and escalation as required.
• Ensure errors and omissions are resolved according to SOP requirements.
• Work in accordance with cGMP, health and safety requirements.

Skills

Quality control

GMP knowledge

Microsoft Word

Microsoft Excel

Communication skills

Teamwork

Education

High School Diploma or GED

Associate's or Bachelor's Degree preferred

Job description

American Regent, Inc. is seeking a QA-focused professional to ensure quality in assigned areas by executing site policies, procedures, programs, and work instructions in a FDA-regulated environment.

You will perform verifications, packaging inspections, AQL checks, and product release activities while maintaining cGMP and safety standards. The role requires strong organizational and communication skills and flexibility to work overtime as needed.