Description:

• The QC Investigations Expert is responsible for leading manufacturing and QC investigation reports in support of cell therapy manufacturing operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems.
• Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
• Lead investigations and cross functional investigation teams, and close reports in a timely manner
• Interview personnel within QC and provide quality insight to complete laboratory investigation reports in 1QEM.
• Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.
• Ensure all investigations are completed in a timely manner.
• Notify stakeholders of any delays in a timely manner.
• Provide technical support for manufacturing investigations / CAPAs / change controls
• Handle complex issues and solve problems with minimal guidance.
• Provide training to new investigations team members
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
• Build strong cross-functional and interdepartmental partnerships to ensure seamless execution of investigations and interface closely with different functional organizations, including Quality Assurance teams. Compliance
• Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
• May Initiate change control documentation
• Identify functional area SMEs to perform impact assessments as part of the change management process.
• Support deviation investigation defense during audits and site inspections for QC compliance related inquiries Key Performance Indicators
• Timely delivery on commitments with and departmental KPIs
• Timely responses and solutions to investigations
• Efficient and flexible usage of the available resources
• Compliance to all relevant company policies and guidelines

Qualifications:

• Bachelor’s degree and 2-4 years of related pharmaceutical / biopharmaceutical work experience; OR
• Master’s degree and 2-3 years of work experience.
• Minimum of 2 years of experience in a cGMP environment / commercial manufacturing.
• Extensive experience in a regulated GMP environment, preferably within QC operations in a cell therapy company.
• Knowledge of cGMP regulations and quality standards relevant to cell therapy manufacturing.
• Working experience of deviation investigations utilizing root cause analysis tools.
• Working experience in the CAPA process and ability to identify and verify effectiveness.
• Technical writing skills and ability to collaborate effectively in cross functional teams.
• Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
• Ability to support health authority inspections.
• Knowledge of data trending and tracking, including use of statistical analysis software a plus.
• Advanced knowledge and implementation of data integrity principles.
• Excellent communication, presentation, and interpersonal skills to effectively train diverse audiences.
• Strong analytical and problem-solving skills.
• Ability to function in a rapidly changing environment & handle multiple priorities.
• Ability to set priorities, manage timelines and effectively react/manage changing priorities.
• Ability to work with management (global and site) and support corporate and departmental goals
• Ability to collaborate cross functionally to drive operational and quality excellence.
• Advanced organizational and time management skills.
• Ability to work independently and as part of a team to achieve quality objectives.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Ability to work collaboratively in a high-paced team environment, meet deadlines and prioritize work for multiple teams/programs

Please refer the Job description for details