Senior Quality Assurance Specialist (GMP & Microbiology)

Goodier Cosmetics; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Goodier Cosmetics is seeking a Quality Associate III in Dallas, TX to perform advanced quality functions within the company’s quality program. You will ensure products released conform to regulatory and quality specs, and may lead or train QC Inspectors.

Responsibilities include GMP reviews, COA preparation, QMS release, data trending, and cross-functional collaboration to ensure timely product disposition and adherence to cGMP and Goodier standards.

Qualifications

• Must have a high school diploma or equivalent.
• 5+ years quality experience in a cGMP or regulated industry.
• 3+ years Microbiology data management in a Microbiology Lab.
• Experience in OTC Drug / Cosmetic / Medical Device manufacturing preferred.
• Proficiency in English (written and spoken).
• Strong attention to detail and integrity.
• Excellent communication skills (verbal and written).
• Knowledge of GMP (21 CFR 210, 211) and Good Documentation Practices.
• Strong math skills (fractions and percentages) and basic math.
• Proficiency with SAP and Quality Management System software; MS Office/TEAMS.

Responsibilities

• Execute GMP reviews for Production Records, ensuring complete documentation compliance with cGMPs and Good Documentation Practices.
• Create and issue Finished Good Lot codes to Production. Serve as the primary trainer for new Quality Assurance Inspectors.
• Provide assistance with quality evaluations and release of materials, products, equipment and facilities where required.
• Perform, audit, verify, document and report AQL inspections and testing to ensure compliance with requirements for Finished Goods and/or Components.
• Perform release of components and/or product for filling or distribution (systematically and/or physically as required per Goodier QMS processes). Prepare product COA documentation as required.
• Elevate observed quality issues to Operations and/or Quality leadership to drive quick resolution, drive equipment adjustments, and coordinate additional actions / inspections as needed.
• Prepare and issue Quality Alerts as required for observed non-conformances.
• Support management of Finished Good rework lots and product or components that are on hold.
• Collect, organize, and prepare samples for third party test labs (3PL) testing.
• Review Microbiological test reports for accuracy and compliance to specifications.
• Input and maintain all microbiological test data in quality databases and/or electronic systems. Execute data trending as requested.
• Perform Environmental Audit testing.
• Prepare, organize, document, archive and manage the life cycle of Finished Product retain samples.
• Interface with all departments and other cross-functional colleagues to ensure systems and processes are in accordance with cGMP and Goodier standards and to ensure timely product and material disposition.
• Observe and monitor activity in production areas to assure adherence to procedures, Good Manufacturing Practices (cGMPs), and Good Documentation Practices.
• Perform other duties as assigned.

Skills

Quality experience

Microbiology data management

English proficiency

Communication skills

GMP knowledge

Mathematical skills

Time management

Team player

Attention to detail

Problem solving

Education

High school diploma or equivalent

Tools

SAP

Quality Management System Software

Microsoft Outlook

Word

Excel

TEAMS

Job description

Goodier Cosmetics is seeking a Quality Associate III in Dallas, TX to perform advanced quality functions within the company’s quality program. You will ensure products released conform to regulatory and quality specs, and may lead or train QC Inspectors.

Responsibilities include GMP reviews, COA preparation, QMS release, data trending, and cross-functional collaboration to ensure timely product disposition and adherence to cGMP and Goodier standards.