Roche-posted 9 months ago
$39,000 - $72,400/Yr
Full-time
Branchburg, NJ
Chemical Manufacturing

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. The Batch Record Reviewer I performs an accurate and timely review of batch records, utilizing electronic systems for verification of information to ensure conforming product is dispositioned appropriately as per global standard procedures.

  • Perform a cGMP/GDP review of hard copy and/or electronic batch records and disposition products.
  • Ensure nonconforming product is identified and appropriately controlled, and conforming product is appropriately dispositioned for use.
  • Maintain workload and priorities using inputs from business requirements, SAP, and/or internal customer needs.
  • Input production data and verify other work output data from appropriate system (e.g. SAP/MES) and maintain documentation in accordance with established procedures.
  • Navigate electronic management systems to verify or obtain applicable information.
  • Interface with the Operators, Quality, or other departments to address any questions or concerns with documentation.
  • Print batch records or perform PreProduction steps in eBR for production as required.
  • Prepare records for development and validation runs, including redlining records as required.
  • You hold a High School Diploma or equivalent.
  • Less than 1 year of experience performing document review and/or working in a manufacturing environment.
  • Good communication and teamwork skills are required.
  • Ability to work under cGMP guidelines.
  • Strong verbal/written skills are required.
  • Ability to multitask and prioritize.
  • Comfortable using and learning multiple computer systems.
  • Discretionary annual bonus may be available based on individual and Company performance.
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