Job Description

The Sr. Technical Writer is responsible for performing site NCR, Significant SNCRs investigations, authoring CAPAs, SOPs, Clinical Batch Records, and miscellaneous technical transfer documentation as needed. The candidate will execute these investigative tasks utilizing tools, identifying the root cause, documenting the results and processing the relevant records, collaborating with impacted departments to determine appropriate corrective or preventive actions, related effectiveness criteria. You will be supporting the Development and Pre-Commercial Services.

Responsibilities:

• Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation.
• Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams.
• Provide relevant experience for training manufacturing and technical personnel both directly and indirectly.
• Establish a scalable framework and organization for execution of technical and quality documentation.
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
• Confirm corrections/containment identified based on the investigation results
• Determine the appropriate data sources to be evaluated for the investigation and obtain the required data
• Investigate the root cause(s) of the issue and document the investigation results
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan
• Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)
• Manage multiple investigations at any given time
• Responsible for speaking to clients and regulatory authorities to explain investigations

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