QA Operations Associate I – GMP & Packaging

VetJobs; New Albany (OH); On-site; USD 42,000 - 62,000; Full time

Job summary

American Regent in New Albany, OH is seeking a Quality Assurance Technician to ensure GMP-compliant operations on the packaging line and in inspection areas. The role includes verifications, material release, logbook management, and collaboration with shipping activities.

The position requires a High School Diploma or GED, with preference for Associates or Bachelors degrees and at least 1 year in a FDA-regulated environment. On-site work with potential overtime.

Qualifications

• High School Diploma or GED required; Associates/Bachelors preferred.
• Minimum 1 year experience in FDA regulated environment preferred.
• Ability to work independently; strong organizational and communication skills.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification.
• Conduct accurate verifications and checks as well as process inspections.
• Conduct accurate packaging AQL inspections.
• Identify out of specification product, escalating as required.
• Resolve errors per SOPs and company policies; ensure cGMP compliance.
• Perform component and raw material release.
• Maintain room, area and equipment clearances.
• Review Bills of Materials.
• Participate in Media Fill and maintain qualification.
• Generate logbooks and labels; support product shipping activities.
• Perform any other tasks/duties as assigned by management.

Skills

Attention to detail

Interpersonal skills

Strong communication

Education

High School/GED

Associates or Bachelor's degree preferred

Tools

Microsoft Word

Excel

Job description

American Regent in New Albany, OH is seeking a Quality Assurance Technician to ensure GMP-compliant operations on the packaging line and in inspection areas. The role includes verifications, material release, logbook management, and collaboration with shipping activities.

The position requires a High School Diploma or GED, with preference for Associates or Bachelors degrees and at least 1 year in a FDA-regulated environment. On-site work with potential overtime.