Overview
QA Batch Disposition Specialist Jobs in Raritan, New Jersey, USA at Legend Biotech US
Legend Biotech is seeking a QA Batch Disposition Specialist as part of theQuality 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).
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.
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.
Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements.
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.
Collaborate with (cross) functional departments to resolve issues related to batch review/release.
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.
Minimum of 4+ years’ experience in Quality Assurance Biotech/Pharmaceutical industry experience. Knowledge of cGMP regulations and FDA/EU guidance.
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.
Ability to lift 20 lbs.
Report to work on-time and according to the company policy.
Perform other duties as assigned.
Practice good interpersonal and communication skills.
Learn new skills, procedures and processes as assigned by management.
Strong proficiency utilizing electronic Quality Systems.
Utilizes tools within MS Office and other systems to improve business effectiveness.
Assist in troubleshooting issues related to manufacturing and batch release.
Ability to deal with complexity across the drug product and the associated manufacturing process.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
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Title: QA Batch Disposition Specialist
Company: Legend Biotech US
Location: Raritan, New Jersey, USA
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
