Lead QA Associate - GMP/Regulatory Compliance & Training

Goodier; Dallas (TX); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Goodier is seeking a Quality Associate III in Dallas, TX to perform advanced QA functions within the quality program and report to QA leadership. The role may lead or train inspectors and supports cGMP compliance across product releases.

Responsibilities include reviewing Production Records, issuing lot codes, performing QA testing and COA preparation, and coordinating with operations to resolve issues promptly.

Qualifications

• High school diploma or equivalent.
• Quality experience (5+ years) in a cGMP or regulated industry is required.
• 3+ years in a Microbiology Lab for microbiology data management.
• OTC Drug / Cosmetic / Medical Device manufacturing experience preferred.
• Ability to read, write, and understand English.
• Integrity, accuracy, and attention to detail are essential.
• Excellent verbal and written communication skills.
• Knowledge of cGMP (21 CFR 210, 211) and Good Documentation Practices.

Responsibilities

• Execute GMP reviews for Production Records and ensure documentation compliance.
• Create and issue Finished Good Lot codes; train new quality inspectors.
• Assist with quality evaluations and release of materials, products, equipment.
• Perform AQL inspections and testing to ensure finished goods compliance.
• Release components/products for filling or distribution per QMS processes.
• Prepare COA documentation as required and escalate issues to leadership.
• Manage rework lots and items on hold; support fast resolution actions.
• Collect samples for third party testing and organize data trends.
• Review microbiological test reports for accuracy and compliance.
• Input microbiological data into quality databases and perform trending.
• Conduct environmental audit testing and maintain sample life cycles.
• Interface with cross-functional teams to ensure cGMP compliance.

Skills

Quality Assurance

Leadership

Documentation

Analytical thinking

Education

High school diploma or equivalent

Tools

SAP

Quality Management System

Microsoft Outlook

Word

Excel

TEAMS

Job description

Goodier is seeking a Quality Associate III in Dallas, TX to perform advanced QA functions within the quality program and report to QA leadership. The role may lead or train inspectors and supports cGMP compliance across product releases.

Responsibilities include reviewing Production Records, issuing lot codes, performing QA testing and COA preparation, and coordinating with operations to resolve issues promptly.