QA Operations Associate I — GMP Quality & Compliance

American Regent, Inc.; New Albany (IN); On-site; USD 42,000 - 64,000; Full time

Job summary

American Regent, Inc. seeks a Quality Assurance professional to ensure GMP compliance and product quality in assigned areas. You will execute site policies, conduct line clearances, and perform packaging inspections and material releases.

The role requires independent work, strong communication, and the ability to escalate issues per SOPs. Applicants should have a high school diploma or GED, with preferred college degrees and FDA-regulated experience.

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.
• Must be able to work independently.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational, interpersonal and communication skills required.
• Ability to take feedback constructively and function in a team-oriented environment.
• Ability to work 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.
• Conduct accurate packaging AQL inspections.
• Identify out of specification product, ensuring segregation and escalation, as required.
• Ensure errors and omissions are resolved according to SOP requirements.
• Ensure all work is performed and documented per company policies, cGMP, health and safety requirements.
• Conduct component and raw material release.
• Conduct chart monitoring and escalation as required.
• Support product shipping activities and perform quality verifications.
• Generate logbooks and sheets/labels.
• Review Bills of Materials.
• Basic knowledge of cGMP and regulatory documents.
• Achieve and maintain clean side and sterile side gowns qualifications.
• Achieve and maintain Class A qualification.
• Perform room, area and equipment clearances.
• Participate in Media Fill and maintain qualification.
• Able to perform tasks with minimal error rate.
• Perform other duties as assigned by management.

Skills

MS Word

MS Excel

Independent work

Communication skills

Teamwork/overtime

Education

High School Diploma or GED

Associate or Bachelor’s degree preferred

1 year FDA-regulated experience

Tools

Microsoft Word

Microsoft Excel

Job description

American Regent, Inc. seeks a Quality Assurance professional to ensure GMP compliance and product quality in assigned areas. You will execute site policies, conduct line clearances, and perform packaging inspections and material releases.

The role requires independent work, strong communication, and the ability to escalate issues per SOPs. Applicants should have a high school diploma or GED, with preferred college degrees and FDA-regulated experience.