We are currently looking for a cGMP Technical Writer who will be responsible for writing, reviewing and driving production and quality documentation to approval.
• The Technical Document Writer will be responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals.
• Additional responsibilities might include tracking of the daily, weekly and monthly forecasted documentation priorities required to meet output quotas.
Key responsibilities/essential functions:
• Originate, revise and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records.
• Compile and draft procedural documentation using standard electronic publishing tools.
• Create and maintain templates for cGMP documents.
• Collaborate with individuals from various internal functional areas to generate and review new equipment, processing, set-up and operational documents within agreed upon timelines.
• Interview subject matter experts to obtain details in order to accurately capture content material.
• Demonstrate effective written and verbal communication skills.
• Monitor the flow of production documents and adjust workload and resources in an appropriate, organized and efficient manner.
• Work with cross-functional teams on the implementation of process improvement initiatives to increase quality in cGMP documentation.
• Demonstrate an ability to multi-task and manage multiple projects independently
• Maintain a safe work environment for self and staff.
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC