Legend Biotech is seeking a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey.

Role Overview

The QA Shop Floor Supervisor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.

Key Responsibilities

• Read, interpret and revise documents such as SOPs, work instructions.
• Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
• Harmonize with Environmental, Health, and Safety personnel, Product Development, andQuality/Manufacturing personnel.
• Independently makes appropriate and compliant GMP decisions.
• Independently resolves problems through the use of quality systems.
• Develop improvement ideas and independently implement associated solutions.
• Support QPIP team development.
• Must be able to be Aseptic Gown Qualified
• Possess the ability to positively influence peers, key stakeholders and management.
• Generates shift schedules, to ensure efficient coverage for all operational needs.
• Maintain individual training completion in a compliant state.
• Supports the completion of corrective and preventive actions, as necessary.
• Supports internal/external audits.
• Supports Quality risk assessment teams.
• Review/approve documents as a Quality on the Floor Subject Matter Expert (SME).
• Remain current in skills and industry trends.

Requirements

• Minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical
  discipline is required.
• Minimum of 6 years relevant work experience is required.
• It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• A minimum of 2 years of experience with quality support in clinical manufacture is preferred. A minimum of 1 year of leadership experience is also required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures
• Must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Excellent written and verbal communication skills
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience directly supervising employees is preferred.
• Ability to work with and lead others in a team environment.
• Demonstrated ability to develop and set long-term objectives.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Experience reviewing/auditing documentation including but not limited to: Batch Records, SOPs, Work Instructions, Validation protocols.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Must have flexibility to work on weekends

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