Batch Record Reviewer

Philip Morris•Aurora, CO

12h•Onsite

About The Position

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

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.
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 preferred.

Responsibilities

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.
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.