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The Principal Technical Writer is responsible for performing site Non-Conformance Report (NCR), Significant SNCRs investigations, authoring CAPAs, standard operating procedures (SOPs), Clinical Batch Records, and miscellaneous technical transfer documentation as needed. This role will also play a critical role supporting training for operators. The candidate will execute these investigative tasks utilizing tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions, related effectiveness criteria. Functioning in an interdepartmental capacity, this individual will author Batch records and technical documentation alongside Manufacturing and Technical Transfer personnel. Personnel filling this role will be supporting the Development and Pre-Commercial Services (DPCS) group within the Bloomington facility. The initial scope of role will be to perform duties as described with the opportunity to build a scalable organization of direct reports in the future. This candidate will sit onsite at the Bloomington facility and report to the Director of DPCS.