Specialist, QA Process Excellence

Legend Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities 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 operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams.

Key Responsibilities

• Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities.
• Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations.
• Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation.
• Assist in the development of process, operational, and quality improvements for manufacturing.
• Assist in the review and development of process-related protocols and documentation.
• Provide technical quality oversight for electronic batch records.
• Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems.
• Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations.
• Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.
• Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities.
• Ability to work independently perform assigned tasks.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• May support CSV activities as needed.
• May support equipment qualification activities as needed.
• Drive continuous improvement. 
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Requirements

• A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required.
• 5+ years relevant work experience or equivalent. 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. A portion of the 5 years must include quality assurance experience.
• Strong knowledge of cell therapy processes strongly preferred.
• Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.
• Experience with Computer System Validation (CSV) is a plus.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
• Experience reviewing/auditing GMP documentation.
• 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 escalate to management when required.
• Detail-oriented and able to 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.
• Strong proficiency with using Microsoft Office applications. 

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