QA Associate - Systems

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

Position Description, Functions, Duties and Tasks:

• Oversee specific systems or functional areas as assigned
• Prepare, review, redline, and/or approve GMP documents supporting the site (Procedures, specifications, protocols, reports, change controls, deviations, etc.)
• Implement and maintain systems for complete documentation and control of all required records, logs, and instructions necessary for compliance with cGMP.
• Evaluate the quality impact for any GMP related incidents, triage initial corrective actions, and support the long-term resolutions.
• Participate in self led and/or regulatory inspections.
• Educate site personnel on quality matters.
• Function as the back-up for other QA colleagues.
• Track and report issues.
• Evaluate and execute Change Control, documentation, and drawing requests.
• Route-and-release documentation in the Quality System.
• Perform training for new and existing team members, prepare training materials as necessary.
• Perform Deviation Investigations.
• Verify and approve Action plan for Change Control.
• Perform walk-through of GMP areas.
• Complete assigned CAPAs.
• Assist in metric reporting to help drive process improvement for quality systems.

Additional Preferences:

• Demonstrated Project Management Skills
• Detailed and Results Oriented
• Solid Computer Skills - Microsoft Office / SAP / SE Suite
• Strong Interpersonal Skills
• Ability to work effectively with respect for others in a team environment
• Excellent communication and organization skills
• adapt readily to change and have the desire to experience new challenges and opportunities.
• this position must provide hands‑on support to all plant personnel in a 24/7 work environment and be on call to provide 'over the phone' or 'on site' support and direction
• must be able to travel to all areas of the plant which may include walking, climbing, various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building

Minimum Qualification (Education, Experience and/or Training, Required Certifications):

Education:

• Bachelor of Science Degree (4 year college)
• or
• Associate's Degree with 2-3 years work experience in a GMP environment
• or
• 10 years work experience in GMP regulated environment with pharmaceutical experience

Experience:

• Demonstrated relevant experience (Quality Assurance, Quality Control, Engineering, Operations, Technology) in a manufacturing facility regulated by the FDA and in compliance with cGMP.
• Excellent verbal and written communication skills tailored to the appropriate audience.
• Ability to work well at all levels within the organization, comfortable in a manufacturing environment.
• Good interpersonal skills, planning, organization and prioritizing are essential.
• Team building skills, along with the ability to facilitate action plans.
• Must have knowledge of computer systems and software applications, including Microsoft Office applications.

What do we offer?

• Competitive Salary
• Competitive Benefits Package and Employee Assistance Program
• 401(k) Plan + Company Match
• Vacation + End of Year Vacation (Company Sponsored)
• Growth Opportunities to expand your career