AddressLegend Biotech is seeking anInvestigations Supervisoras part of the Technical Operations team based in Raritan, New Jersey.
Role Overview
The CAR -T Investigation Supervisor will work with the investigation team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.
Key Responsibilities
- Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.
- Assign investigations to team members and track them to completion.
- Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
- Perform investigations and train new investigators.
- Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
- Support tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.
- Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
- Implement process improvements within the change control system.
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- Partner with all stakeholders to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Maintains various databases of production information.
- Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
- Review and approve SOP and Batch record revisions.
Requirements
- BS/BA required in technical discipline: Engineering, science or similar field.
- A minimum of six (6) years of professional relevant business experience.
- Demonstrated experience in completing complex investigations independently.
- Knowledge and solid understanding of cGMP regulations and FDA/EU guidance.
- Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP.
- Excellent written and oral communication skills.
- Ability to respond to sensitive inquiries or complaints from top managers, regulatory agencies, or members of the business community.
- Experience with internal and external regulatory audits.
- Ability to utilize various standard programs for data entry and word processing.
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