QA Operations Associate I: GMP & Quality Assurance

americanregent; New Albany (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent is seeking a Quality Assurance/Quality Control professional in Ohio to ensure product quality and GMP compliance across assigned areas. Responsibilities include verifications, inspections, AQL checks, and release of components and raw materials.

The role requires a High School Diploma or GED with preference for an Associate or Bachelor’s degree, and experience in FDA-regulated environments. Strong organization and communication skills are essential; travel and overtime may be

Qualifications

• Intermediate skills in Microsoft Word and Excel are required.
• Successful candidate must be able to work independently.
• Experience in FDA-regulated or similarly regulated environments is preferred.
• Strong organizational, interpersonal and communication skills are required.

Responsibilities

• Ensure packaging line and inspection room clearance qualification.
• Conduct accurate verifications, process inspections and AQL inspections.
• Identify out-of-specification products and ensure proper segregation and escalation.
• Perform room, area and equipment clearances and maintain cGMP compliance.
• Support product shipping activities and provide quality oversight and verifications.
• Review Bills of Materials and generate necessary logs and labels.

Skills

MS Word

MS Excel

Education

High School Diploma or GED

Associates or Bachelor's Degree preferred

Job description

American Regent is seeking a Quality Assurance/Quality Control professional in Ohio to ensure product quality and GMP compliance across assigned areas. Responsibilities include verifications, inspections, AQL checks, and release of components and raw materials.

The role requires a High School Diploma or GED with preference for an Associate or Bachelor’s degree, and experience in FDA-regulated environments. Strong organization and communication skills are essential; travel and overtime may be