Batch Record Reviewer

Philip Morris International U.S.•Aurora, CO

1d•Onsite

About The Position

Philip Morris International is seeking a Batch Record Reviewer to join the quality department at its production facility in Aurora, Colorado. The position reviews executed batch records, manages nonconformities and CAPA activities, and helps ensure products meet quality requirements for commercial release. It provides quality reporting, data analysis, and technical support while maintaining compliance with the quality management system (QMS), FDA cGMP, and applicable standards. The hourly pay rate is $33.00.

Requirements

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.
Degree in biological sciences, physical sciences, or engineering, or equivalent experience.
At least 2 years of experience in FMCG manufacturing, quality, or related environments.
Experience reviewing manufacturing batch records and quality documentation.

Nice To Haves

FDA-regulated industry experience.

Responsibilities

Review batch production and release records for accuracy, completeness, and QMS compliance.
Support the 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 and 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.