Sr. QA Validation Specialist, CSV & Equipment

Legend Biotech is seeking a Sr. QA Validation Specialist, CSV & Equipment as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. QA Validation Specialist, CSV & Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity.

Key Responsibilities

• Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site
• Review and approve qualification/validation documentation (specifications, protocols, reports).
• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration).
• Provide expertise and solutions to issues regarding qualification and validation strategies and documentation.
• Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems.
• Assist in the development of validation and qualification related policies, procedures, templates, forms.
• Provides quality oversight on data integrity of systems, instruments, and equipment used at the site.
• Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.
• Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site.
• Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Drive continuous improvement.
• Provide training and guidance to other members of the team.
• Other duties may be assigned, as necessary. 

Requirements

• A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required.
• 7+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus.
• Strong knowledge of GxP compliance.
• Experience in cGMP regulatory body audits.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information.
• Ability to work independently and be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow procedures closely.
• Ability to identify and assess possible gaps and work collaboratively to address such issues.
• Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Experience reviewing/auditing GMP documentation.
• Strong proficiency with using Microsoft Office applications. 

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