Car-t Operations Batch Record Reviewer
Il y a 7 mois
**Company Information**
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
**Position Overview**
The CAR-T Operations Batch Record Reviewer is an exempt level position working within Technical Operations team, responsible for the batch record review of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule. The Batch Record Reviewer will work in a detail-oriented compliant manner.
**Major 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
- Perform First Quality review within Operations for executed batch records daily
- Check completeness of all associated documentation ensuring compliance with written Policies and procedures as required for batch release
- 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/support 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, COMET and eLIMS.
- Initiate product non-conformance investigations and deviation investigations in COMET as necessary
- Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issue
**Qualification**
**Education**:
- Bachelor's or Master's degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
**Experience**:
- A minimum of 1 year within a cGMP or ATMP environment in the biotech/biopharma industry is preferred
- Knowledge of GMP is preferred
**Capabilities, Knowledge, and skills**:
- 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. Good interpersonal skills and the ability to work well in a team environment is a must
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Good developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment,.
- Strong analytical, problem solving, pragmatic and positive critical thinking skills
- Can do attitude, Right first time and Hands-on approach
- Tenacity to drive issues until resolved and deliver results
- Self-motivated, enthusiastic personality, team player
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- Excellent communication and organizational behaviors skills are required.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
- Proficiency with MES/EBR is a nice to have
- Ability to accommodate shift work including evenings and weekends as required by the process.
- Ability to accommodate unplanned overtime on little to no prior notice
**Language(s)**:
- Dutch and English#LI-AG1
Legend Biotech maintains a drug-free workplace.
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