Senior Technical Writer Contractor - 246143

Senior Technical Writer Contractor - 246143

1 week ago Be among the first 25 applicants

This range is provided by Medix™. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00 / hr - $50.00 / hr

Direct message the job poster from Medix™

Helping Sponsors take their products from conception ? commercialization

The Sr. Technical Writer is responsible for performing site NCR, Signi?cant 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 De?ne / Measure / Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools.
• Con?rm corrections / containment identi?ed 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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