GMP QA Associate — Quality, Compliance & Growth

Union Agener; Augusta (GA); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Benefits package

401(k) with match

Paid vacation

Career growth opportunities

Job summary

Union Agener in Augusta, GA seeks a Quality Assurance professional to oversee GMP documentation, review procedures and specifications, and assure cGMP compliance. The role includes evaluating quality impacts, supporting inspections, and educating site personnel in quality matters.

The candidate should be capable of back-up QA support, managing change controls, training, deviation investigations, CAPAs, and metrics reporting to drive continuous improvement in quality systems.

Qualifications

• Bachelor's degree in a science field and FDA cGMP experience.
• Excellent verbal and written communication skills tailored to the audience.
• Ability to work across all levels in a manufacturing environment.
• Strong planning, organization, prioritization, and team facilitation.
• Knowledge of computer systems and software applications.

Responsibilities

• Oversee specific systems or functional areas as assigned.
• Prepare, review, redline, and approve GMP documents (procedures, specs, protocols, reports).
• Implement and maintain systems for complete documentation and record control for compliance with cGMP.
• Evaluate quality impact for GMP incidents and support long-term resolutions.
• Participate in regulatory inspections and educate site personnel on quality matters.
• Act as back-up for other QA colleagues and track issues.
• Evaluate and execute Change Control, documentation, and drawing requests.
• Route-and-release documentation in the Quality System and perform trainings.
• Conduct Deviation Investigations and approve action plans for Change Control.
• Walk-through GMP areas and complete assigned CAPAs.
• Assist in metric reporting to drive process improvement for quality systems.

Skills

Project management

Communication

Team collaboration

Education

Bachelor of Science Degree

Tools

SAP

SE Suite

Microsoft Office

Job description

Union Agener in Augusta, GA seeks a Quality Assurance professional to oversee GMP documentation, review procedures and specifications, and assure cGMP compliance. The role includes evaluating quality impacts, supporting inspections, and educating site personnel in quality matters.

The candidate should be capable of back-up QA support, managing change controls, training, deviation investigations, CAPAs, and metrics reporting to drive continuous improvement in quality systems.