Senior QA Specialist - GMP & 3PL Quality Oversight

Prestige Brands; Clayton (IN); On-site; USD 65,000 - 80,000; Full time

Job summary

Prestige Consumer Healthcare is seeking a senior Quality Assurance Specialist to oversee GMP-compliant QA activities at a 3PL facility in Clayton, IN. The role supports quality systems, investigations, audits, CAPAs, and continuous improvement initiatives, acting as a technical quality resource without direct reports.

The position emphasizes collaboration with Supply Chain, Regulatory Affairs, and Quality leadership to resolve issues and ensure compliance across operations.

Qualifications

• Knowledge of FDA 21 CFR Parts 111, 210 and 211 and applicable cGMP pharmaceutical quality requirements.
• Minimum of 3-5 years of Quality Assurance experience in a GMP-regulated environment.
• Experience conducting investigations, managing CAPAs, supporting supplier quality activities, auditing, and quality systems preferred.

Responsibilities

• Establish and maintain effective coordination with suppliers, site personnel, management and 3PL.
• Lead nonconformance investigations and CAPA closure.
• Oversee rework/label operations to correct nonconformances.
• Coordinate supplier audits and evaluate corrective actions.
• Draft and maintain SOPs and quality documentation for GMP compliance.

Skills

Quality Systems

CAPA

Audits

SOPs

GMP

Education

Bachelor's degree in Life Sciences

Tools

SAP

Job description

Prestige Consumer Healthcare is seeking a senior Quality Assurance Specialist to oversee GMP-compliant QA activities at a 3PL facility in Clayton, IN. The role supports quality systems, investigations, audits, CAPAs, and continuous improvement initiatives, acting as a technical quality resource without direct reports.

The position emphasizes collaboration with Supply Chain, Regulatory Affairs, and Quality leadership to resolve issues and ensure compliance across operations.