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.
Benefits:
401(k) Health Insurance Dental Insurance Vision Insurance Career Growth Opportunities
