Batch Record & Document Coordinator
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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
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). 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 a 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.
Schedule: Sat-Wed 1st Shift
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.
- Electronic Batch Record), and a Learning Management System.
- Strong interpersonal skills and the ability to work well in a team environment is a must.
- Language: English
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The anticipated base pay range is:
$66,063 - $86,706 USD
Benefits:
We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
EEO Statement
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 applicable law.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug-free workplace.
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