Batch Record Reviewer

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

Be a part of a revolutionary change!

At Philip Morris International (PMI), we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free future.

With huge change, comes huge opportunity. So, if you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Our success depends on people who are committed to our purpose and have an appetite for progress.

We are currently seeking a Batch Record Reviewer to join our quality department in Aurora, Colorado production facility.

Hourly pay rate: $33.00 an hour

Position Summary

Review executed batch records, manage nonconformities and CAPA activities, and ensure products meet quality requirements for commercial release. Provide quality reporting, data analysis, and technical support while maintaining compliance with QMS, FDA cGMP, and applicable standards.

Key Responsibilities

• Review batch production and release records for accuracy, completeness, and QMS compliance.
• Support development, revision, and archiving of batch documentation and records.
• Investigate nonconforming products, deviations, and quality issues; determine disposition and implement CAPA.
• Perform trend analysis and monitor quality data to identify risks and preventive actions.
• Generate quality reports and support KPI monitoring and data integrity initiatives.
• Provide quality risk assessments, on-floor manufacturing support, and guidance on quality standards.
• Support product/process improvements, validation activities, and new product introductions.
• Communicate quality-related information across departments and contribute to continuous improvement efforts.
• Train manufacturing personnel on quality processes, procedures, and compliance requirements.
• Ensure adherence to safety, environmental, and regulatory standards.
  
  

Knowledge & Skills

• Knowledge of Quality Systems, CAPA, root cause analysis, data review, and documentation practices.
• Understanding of FDA cGMP and ISO standards.
• Strong analytical, reporting, problem-solving, and statistical analysis skills.
• Detail-oriented with excellent communication and teamwork abilities.
  
  

Education

• Degree in Biological Sciences, Physical Sciences, Engineering, or equivalent experience.
  
  

Experience

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

Philip Morris International Inc.'s U.S. businesses are invested in America's future and advancing a smoke-free nation. The businesses are committed to providing the approximately 25 million legal-age consumers who smoke cigarettes with better, smoke-free alternatives and to ensuring the products are marketed responsibly. From PMI's global headquarters in Stamford, CT, and other locations nationwide, PMI U.S. contributes leadership, jobs, investment, and innovation in the U.S. The U.S. businesses employ more than 3,000 people across America and operate product manufacturing facilities. For more information, please visit www.uspmi.com. Philip Morris International (PMI) is an Equal Opportunity Employer.

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