QA Investigations Lead II

Key Responsibilities

• Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).
• Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented.
• Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.
• Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed.
• Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
• Collaborate with site personnel to provide guidance and determine resolution for end-to-end manufacturing issues.
• Avoid exposure to and handling of biological materials and hazardous chemicals.
• Perform analysis on quality indicating data and identifying trends.
• Contribute to maintain investigation compliance metrics.
• Support investigation process improvement initiatives.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 2-4 years relevant work experience is required.
• Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy is preferable.
• Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products.
• Great attention to detail and ability to follow the procedures.
• Highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Excellent organizational skills with the ability to simplify and clearly communicate complex concepts.
• Excellent verbal, written and presentation capabilities.
• Able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
• Strong leadership skills and effectively develop others.
• Able to collaborate well with stakeholders, customers and peers.
• Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Ability to discern the criticality of issues and communicate to management regarding complex issues.
• Able to manage conflict and issues that arise with internal or external customers.