Senior QA Specialist - GMP & 3PL Audits

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

Job summary

Prestige Consumer Healthcare seeks a Senior Quality Assurance Specialist to oversee GMP compliance and quality systems at our 3PL partner site in Clayton, IN. The role focuses on investigations, CAPAs, audits, and continuous improvement within the Science & Technology Department.

You will develop SOPs, monitor quality metrics, train Quality Inspectors, and collaborate with Supply Chain, Regulatory Affairs, and Operations to resolve issues and uphold product quality.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Quality, Engineering, or a related discipline preferred.
• 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, personnel, management and 3PL.
• Lead nonconformance investigations, root-cause analysis, CAPAs and monitor effectiveness.
• Oversee rework/re-label operations to correct nonconformances.
• Coordinate supplier audits and manage corrective actions from audits.
• Draft and maintain SOPs and quality system documents for GMP compliance.

Skills

Quality Assurance

Investigations

CAPA

Auditing

GMP Compliance

Data analysis

Microsoft Excel

Education

Bachelor's degree in Life Sciences/related

Tools

SAP

ERP systems

Job description

Prestige Consumer Healthcare seeks a Senior Quality Assurance Specialist to oversee GMP compliance and quality systems at our 3PL partner site in Clayton, IN. The role focuses on investigations, CAPAs, audits, and continuous improvement within the Science & Technology Department.

You will develop SOPs, monitor quality metrics, train Quality Inspectors, and collaborate with Supply Chain, Regulatory Affairs, and Operations to resolve issues and uphold product quality.