QA Change Control Specialist II

Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Change Control Specialist II role is an exempt level position with responsibilities for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for managing change control activities throughout the lifecycle.

Key Responsibilities

• Support and streamline the site change control process.
• Participate in change control process from initiation through completion.
• Schedule and participate in the site change control review board meetings.
• Manage change control metrics reporting.
• Collaborate with functional departments to resolve issues.
• Support drafting of standard operating procedures.
• Support cross-functional projects with many stakeholders.
• Participate in the training program for new members.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Review change controls, SOPs, and other documentation.
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Drive continuous improvement.
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support.

Requirements

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• Minimum of 2 years relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
• Operational experience with electronic quality systems.
• Familiarity with core Quality Management System processes.
• Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
• IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support is a plus.
• Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Effective interpersonal skills with the ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Proficient knowledge of Microsoft Office.
• Experience in quality metrics reporting, analysis and process improvement techniques is a plus.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

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