GMP QA Associate: On-Call Support & Growth

Union Agener, Inc.; Augusta (GA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

401(k) Plan + Company Match

Vacation and year-end vacation paid by

Growth opportunities

Job summary

Union Agener, Inc. is seeking a QA professional to oversee GMP documentation and regulatory compliance at the Augusta site. The role includes reviewing procedures, change controls, deviations, and CAPAs, with on-site support for plant personnel across shifts.

Candidates should have strong communication, project management, and team collaboration skills, plus experience in FDA-regulated environments and cGMP standards.

Qualifications

• Bachelor’s degree or equivalent GMP-related education or training.
• Experience in FDA-regulated manufacturing with cGMP compliance.
• Strong communication and documentation skills.

Responsibilities

• Oversee specific systems or functional areas as assigned.
• Prepare, review, redline, and/or approve GMP documents.
• Implement and maintain systems for complete documentation and control of records for cGMP compliance.
• Evaluate quality impact for GMP incidents; triage corrective actions and support resolutions.
• Participate in self-led and regulatory inspections.
• Educate site personnel on quality matters.
• Serve as back-up for other QA colleagues.
• Track and report issues; evaluate and execute Change Control requests.
• Route-and-release documentation in the Quality System.
• Perform training and prepare training materials.
• Perform Deviation Investigations and approve action plans for Change Control.
• Walk-through GMP areas and complete CAPAs.
• Assist in metric reporting to drive process improvement.

Skills

Project management

Detail oriented

Interpersonal skills

Communication skills

Adaptability

On-call support

Team player

Quality Assurance

Quality Control

Engineering

Operations

Technology

Education

Bachelor of Science (4-year college)

Associate's Degree with GMP experience

10 years GMP/pharma experience

Tools

Microsoft Office

SAP

SE Suite

Job description

Union Agener, Inc. is seeking a QA professional to oversee GMP documentation and regulatory compliance at the Augusta site. The role includes reviewing procedures, change controls, deviations, and CAPAs, with on-site support for plant personnel across shifts.

Candidates should have strong communication, project management, and team collaboration skills, plus experience in FDA-regulated environments and cGMP standards.