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Manufacturing Lead Investigator - Boston Massachusetts
Company: Takeda Pharmaceutical Location: Boston, Massachusetts
Posted On: 05/13/2024
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Manufacturing Lead InvestigatorLocation: Cambridge, MAAbout the role:With support the Lead Investigator will lead evaluation and close out of deviations within the established timelines. Will also evaluate and close out Environmental Monitoring excursions and Metrology Out of Tolerance assessments.How you will contribute: - Conduct investigations of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors to determine product impact, identify cause, and identify corrective and preventative actions.
- Build productive working relationships throughout the organization.
- Investigate and document findings and influence assessment for deviations mostly minor, some major
- Provide subject matter expertise on manufacturing process to support deviations owned by other departments
- Author calibration Out of Tolerance (OOT) impact assessments
- Author Environmental Monitoring (EM) excursions impact assessments
- Participate in continuous improvement initiative
- Strives to create fresh solutions to issues.
- Actively participate on teams with internal/external SMEs.
- Assist assigned functional area leads in driving problems to resolution.
- Serves as external spokesperson during Health Agency Inspections on minor matters pertaining to investigationsWhat you bring to Takeda:
- Bachelor's in Science, Engineering or a related discipline
- 2-5 years related experience in the manufacturing and development of biologics or pharmaceuticals
- Previous technical writing experience is ideal
- Provides clear, concise and technically sound written & verbal communications in a timely manner with limited input from manager or senior team members
- Seeks to identify sources of conflict and resolve independently or under the guidance of senior team members / managers.
- Proficient with the following software applications including Microsoft Visio, Project, and SharePoint TrackWise, or equivalent system. LIMS, SAP, OSI/PI applications a plusImportant Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
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