Quality Assurance; GMP Manufacturing

Quality Assurance Specialist (GMP Manufacturing)

Job Summary

The Quality Assurance Specialist is responsible for ensuring product quality, regulatory compliance, and adherence to GMP standards within a manufacturing environment. This role supports production and packaging operations through quality inspections, documentation review, process monitoring, and continuous improvement initiatives. The ideal candidate will have experience working in a GMP-regulated manufacturing setting, strong attention to detail, and a commitment to maintaining the highest quality and compliance standards.

Key

Duties & Responsibilities:

• Monitor manufacturing and packaging operations to ensure compliance with GMP and quality standards.
• Perform routine inspections of production areas and processes.
• Review batch records, production documentation, and quality records for accuracy and completeness.
• Investigate quality issues, non-conformances, and deviations, and assist with corrective actions.
• Support internal audits and regulatory inspections.
• Ensure adherence to GMP requirements and manufacturing floor procedures.
• Collaborate with production teams to drive continuous improvement initiatives.
• Maintain accurate quality documentation and records.
• Assist with employee training related to quality procedures and GMP compliance.

Requirements

• Minimum 4 years of experience in a GMP/cGMP manufacturing environment.
• Experience in pharmaceutical, dietary supplement, or other regulated manufacturing industries preferred.
• Manufacturing floor experience in production or packaging operations.
• High School Diploma or GED required.
• Strong focus on quality, compliance, and process improvement.
• Must be authorized to work in the United States without sponsorship.