Batch Record & Document Coordinator

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Batch Record & Document Coordinator as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

The Batch Record and Documentation Coordinator will work in a detail-oriented compliant manner coordinating the batch record flow, correction, proper and complete documentation.

Key Responsibilities  

• Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
• Assist in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on daily basis.
• Ensure documents like batch records, labels, forms, etc. are printed and available for production.
• Oversee batch records review and completeness of all associated documentation ensuring compliance with written Policies and procedures as required for batch release.
• Perform First Quality review for executed batch records daily.
• Perform other assigned duties as may be required in meeting company objectives.
• Communicate effectively with other departments within the organization and function within a team environment.
• Gather production information to support OOS, Deviation, and CAPA logs.
• Review of specific in-process, and finished product data such as eLims samples data, MES calculations, EBR completeness, SAP data, and Quality Issues.
• Document retrieval from local files and archives, as required for submissions and customer requests.
• Assist in process audits and internal audits as needed.
• Report Error Weekly Metrics (Right the First Time) Error Free, and success Rate found during review to Management.
• Works closely with QA functional teams to align and promote awareness on data integrity and good documentation practices 
• Facilitate and Coordinate with Project teams to enhance, improve and streamline batch records cycle time.
• Navigate through various online platforms, including MES, SAP, Track Wise, and eLIMS.
• Initiate product non-conformance investigations and deviation investigations in Track Wise as necessary.
• Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issues

Requirements

• Position requires a 2-yr Associate Degree. Will consider experienced candidates with a high school diploma or GED.
• A minimum of two years’ experience in a cGMP environment required or related experience.
• Must possess good written and oral communication skills.
• Must be proficient in MS Office Suite and be able to coordinate multiple tasks efficiently.
• Must be willing to learn and be proficient in eLIMs, S4HANA (SAP) , MES (Manufacturing Electronic Batch Record), and a Learning Management System.
• Strong interpersonal skills and the ability to work well in a team environment is a must.

#LI-BZ

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.