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Investigator (Technical Operations/Process)
3 months ago
Legend Biotech is seeking an Investigator (I, II, and Sr.) as part of the Technical Operations team based in Raritan, NJ
Role Overview
The Investigator will be part of Technical Operations team and will be responsible for the investigations of Operations/Technical QIs to determine applicable corrective and preventive actions in accordance with our company regulations and other global health authority regulators such as FDA. Will collaborate cross functionally to close nonconformance records and identify necessary corrections.
Key Responsibilities
- Lead cross functional investigations independently from end to end.
- Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification (CPV)
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- Provide technical expertise in the Technical Operations group, process knowledge of the cell and genetherapy manufacturing, including but not limited to deviations (Quality Issues), investigations, CAPAmanagement.
- Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and ensuring compliance.
- Must have a strong knowledge and experience with cGMP, GCP, GLP, Quality and Compliance.
- Must have strong authorship and be able to critically review investigations, interpret results andgenerate technical conclusion consistent with Quality risk management principles.
- Must be able to effectively prepare communications with interpretation of data analysis and potentialproblems to management and the group with clarity and a high level of accuracy.
- Must provide guidance to other associates in the interpretation of technical issues across aninterdisciplinary team.
- Must be action-oriented and customer-focused, building relationships, problem solving, planning andorganizing, conflict management, resource allocation, coaching others and analytical thinking. Confident in making decisions for minor issues.
- Must be nimble and an agile learner able to assimilate large amount of data quickly and simplify to coherent story to support an investigation.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations forresolution.
- Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met. Must be self-motivated and driven to independently seek out answers.
- Willing to work on shift as required.
- A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
- A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred
- Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Advanced knowledge in cGMP.
- Ability to interpret results and situations and articulate recommendations for resolution.
- Excellent verbal and written communication skills.
- Experience with electronic document management systems.
- Drive CAPA closures and follow up in Effectiveness checks.
- An ability to build strong partnerships and effectively integrate with externalcollaborators to drive projects/programs forward in a matrixed environment.
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