QA Batch Disposition Specialist III

Legend Biotech is seeking a QA Batch Disposition Specialist III as part of the Quality team based in Raritan, NJ.

Role Overview

This exempt-level position is responsible for performing a wide range of activities to support the Manufacturing and release of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities

• Review documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
• Review documentation for miscellaneous activities executed in accordance with Good Documentation Practices (GDP).
• Work in a team based, cross-functional environment to complete tasks required to meet all business objectives.
• Perform regular administrative duties to maintain all manufacturing record which will involve binding and archiving and storage.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations; also, support or facilitate investigations for Product Quality Complaints.
• Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review/ release process.
• Contribute to process improvement.
• Ensure turnaround times are adhered to during review and disposition of the Drug Product deadlines.
• Perform duties/tasks under minimal direction/supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Ensure readiness of manufacturing records for regulatory inspections and internal audits.
• Support of regulatory audits including preparation of documents, presentation to health authorities, and to lead actions in response to potential findings.
• Ability to utilize multiple electronic quality systems and SAP.
• Contribute to the improvement of QA practices to ensure accurate documentation activities, including manual and electronic practices.
• Collaborate with (cross)functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results to allow for timely release of final product batches according to department and business plan in a complex fast paced supply chain organization.
• Contribute to cross-functional projects with stakeholders to establish best practices that will reassure the target turnaround time of a CAR-T product.

Requirements

• Bachelor’s degree required in Life Sciences or Engineering.
• A Minimum of 4+ years’ experience in Quality Assurance Biotech/Pharmaceutical industry experience. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Great diligence to detail and ability to follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Good written and verbal communication skills are required.
• Ability to collaborate well with stakeholders, customers and peers.
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
• Ability to lift 20 lbs.
• Report to work on-time and according to the company policy.
• Perform other duties as assigned.
• Attend departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate positive collaborative approach in the daily execution of procedures.
• Promote and work within a one team environment.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Strong proficiency utilizing electronic Quality Systems per curriculum.
• Utilizes tools within MS Office and other systems to improve business effectiveness.
• Support and contribute to projects.
• Assist in troubleshooting issues related to manufacturing and batch release.
• Interpret a variety of instructions furnished in written, oral, or diagram.
• Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Read and interpret documents such as safety rules, operating instructions and logbooks.
• Review and provide feedback for SOPs.

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