The CAR-T Operations Batch Record Reviewer is an exempt level position within the 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 and compliant manner.
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Major Responsibilities
- Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
- Assisting in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on a daily basis.
- Ensuring documents like batch records, labels, forms, etc., are printed and available for production.
- Performing First Quality review within Operations for executed batch records daily.
- Performing other assigned duties as may be required in meeting company objectives.
- Communicating effectively with other departments within the organization
- Gathering production information to support OOS, Deviation, and CAPA logs.
- Reviewing specific in-process and finished product data such as eLims samples data, MES calculations, EBR completeness, SAP data, and Quality Issues.
- Retrieving documents from local files and archives as required for submissions and customer requests.
- Assisting in process audits and internal audits as needed.
- Reporting/supporting Error Weekly Metrics (Right the First Time) Error Free, and success rate found during review to Management.
- Working closely with QA functional teams to align and promote awareness of data integrity and good documentation practices.
- Facilitating and coordinating with project teams to enhance, improve, and streamline batch records cycle time.
- Initiating product non-conformance investigations and deviation investigations in COMET as necessary.
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The CAR-T Operations Batch Record Reviewer is an exempt level position within the 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 and compliant manner.
Major Responsibilities
- Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
- Assisting in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on a daily basis.
- Ensuring documents like batch records, labels, forms, etc., are printed and available for production.
- Performing First Quality review within Operations for executed batch records daily.
- Performing other assigned duties as may be required in meeting company objectives.
- Communicating effectively with other departments within the organization
- Gathering production information to support OOS, Deviation, and CAPA logs.
...
- Reviewing specific in-process and finished product data such as eLims samples data, MES calculations, EBR completeness, SAP data, and Quality Issues.
- Retrieving documents from local files and archives as required for submissions and customer requests.
- Assisting in process audits and internal audits as needed.
- Reporting/supporting Error Weekly Metrics (Right the First Time) Error Free, and success rate found during review to Management.
- Working closely with QA functional teams to align and promote awareness of data integrity and good documentation practices.
- Facilitating and coordinating with project teams to enhance, improve, and streamline batch records cycle time.
- Initiating product non-conformance investigations and deviation investigations in COMET as necessary.
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