What are the responsibilities and job description for the Batch Record & Document Coordinator position at Legend Biotech?
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.
Key Responsibilities
Legend Biotech maintains a drug-free workplace.
Benefits:
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
- 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
Legend Biotech maintains a drug-free workplace.
Benefits:
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Matched 401K
- Flexible Spending Account
- Health Savings Account
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Paid Maternity Leave
- Paid Paternity Leave
- Pet Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- Legal Insurance
- Commuter Benefits
- Employee Assistance Program