Quality Assurance (GMP Manufacturing)

ClearBridge Executive Search

Rock Hill (SC)

On-site

USD 70,000 - 90,000

Full time

25 hours ago
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Job summary

ClearBridge Executive Search is seeking a Quality Assurance Specialist (GMP Manufacturing) to ensure product quality, regulatory compliance, and adherence to GMP standards in a manufacturing environment. The role supports production and packaging through inspections, documentation review, and continuous improvement initiatives, with emphasis on timely deviations, non-conformances, and internal audits.

Candidates should have at least 4 years in GMP/cGMP settings and be authorized to work in the

Qualifications

  • 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.
  • Strong focus on quality, compliance, and process improvement.

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.

Skills

Quality assurance
GMP compliance
Regulatory compliance
Documentation review

Education

High School Diploma or GED

Job description

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.
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