Technical Writer

Technical Writer

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

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.

Qualifications

• 3+ years of previous technical writing experience in a cGMP pharmaceutical environment. • Experience in manufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements. • Prior experience working in a biotech/pharmaceutical company. • Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills. • Proven ability to communicate complex ideas in a clear, concise manner. • Working knowledge of MS Office Suite and an Electronic Document Management System (EDMS). • Experience with Document Proficiency in Microsoft Office Products.