Quality Batch Records Analyst

Philip Morris International U.S.; Aurora (CO); On-site; USD 39,000 - 52,000; Full time

Job summary

Philip Morris International U.S. in Aurora, Colorado is seeking a Batch Record Reviewer to ensure batch records meet quality requirements for commercial release.

The role focuses on reviewing records, managing nonconformities, and supporting CAPA activities within a compliant QMS environment. You will analyze data, generate quality reports, and work with manufacturing teams to drive improvements, while adhering to FDA cGMP and ISO standards.

Qualifications

• 2+ years of experience in FMCG manufacturing or quality.
• Experience reviewing batch records and quality documentation.
• FDA-regulated industry experience preferred.

Responsibilities

• Review batch records for accuracy and QMS compliance.
• Investigate nonconformities and implement CAPA.
• Generate quality reports and KPI monitoring.
• Support product/process improvements and validations.
• Train personnel on quality processes and compliance.

Skills

Quality Systems

CAPA

Data analysis

FDA cGMP

Statistical analysis

Communication

Teamwork

Education

Biological/Physical Sciences or Engineering degree

Job description

Philip Morris International U.S. in Aurora, Colorado is seeking a Batch Record Reviewer to ensure batch records meet quality requirements for commercial release.

The role focuses on reviewing records, managing nonconformities, and supporting CAPA activities within a compliant QMS environment. You will analyze data, generate quality reports, and work with manufacturing teams to drive improvements, while adhering to FDA cGMP and ISO standards.