Batch Record Reviewer I

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

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.

The opportunity:

• Ability to perform a cGMP/GDP review of hard copy and/or electronic batch records and disposition products.

• Ensure non-conforming product is identified and appropriately controlled, and conforming product is appropriately dispositioned for use. Maintains 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. Ability to navigate electronic management systems to verify or obtain applicable information

• Able to interface with the Operators, Quality, or other departments to address any questions or concerns with documentation.

• May print batch records or perform Pre-Production steps in eBR for production as required. May prepare records for development and validation runs, including redlining records as required.

This position will be performed on site.

Who you are:

Minimum qualifications:

• ​You hold a High School Diploma or equivalent

Preferred qualifications:

• 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 multi-task and prioritize

• Comfortable using and learning multiple computer systems

Relocation benefits are not available for this job posting.

Pay transparency

The expected salary range for this position based on the primary location of Branchburg is 39,000.00 - 72,400.00 USD Annual.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.