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Technical Writer – Quality
6+ Month Contract
The quality writing tech will support quality systems and the global supply chain quality operations area.
Duties/expectations are as follows:
• Prepare and finalize basic and complex process documents as assigned with minimal supervision but as part of a quality team with a senior quality engineer
• Documents must be of high quality in terms of content, as well as organization per regulatory and internal guidance's, clarity, and accuracy, with attention to format and consistency using established templates.
• Documents must be prepared within established timelines and in accordance with internal processes.
• Make decisions that impact presentation in documents that will be viewed by external authorities.
• Work with senior QA on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges.
• Provide updates to team with regard to content as appropriate, as well as processes and timelines
• May provide guidance and oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• May manage the work of document/project team members without authority over them.
• Work collaboratively in a team environment with minimal direction and take a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking, as appropriate.
• Demonstrate excellent listening skills and be proficient at sending clear, convincing, and well-tuned messages through a variety of media including but not limited to business discussions (one-on-one or larger groups) and e-mail messages.
• Audit existing process flows within global supply chain
• Create and appropriate local operating procedures for Q&C related processes and activities.
• Coordinate the effective implementation of Q&C related changes.
• Perform internal assessments to ensure the Quality Management System is effective, and seek continuous improvement of the system.
• To assist in the preparation of Quality System and metrics review on a regular basis.
• Provides audit readiness and ongoing audit support including any corrective actions related to project issues
• Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions.
• Communicates changes to or the introduction of new controlled documents along with any required downstream document management and training activities
• Coaches/trains users of the new process flows
• Identifies areas for process improvement and contributes to their implementation
• Supports the implementation of various new/updated processes and tools
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.